Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA

Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA Maria Fernandez Ramos, Amy Reichlin, Jordan Kase, Joseph Giamelli This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3851197/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Jun, 2024 Read the published version in Journal of Perinatology → Version 1 posted 10 You are reading this latest preprint version Abstract Objective: Review a cohort of preterm infants <29 weeks of gestation at birth and compare morbidities and neurodevelopmental outcomes based on type of PDA closure. Study design: Single center observational retrospective-prospective case control study of premature infants who underwent surgical ligation or percutaneous transcatheter closure of the PDA. Neurodevelopmental testing was done using the Bayley Scales of Infant Development 3rd ed. Results: The percutaneous transcatheter closure group had an older corrected gestational age and weight at the time of procedure, and started enteral feeds and achieved room air status at an earlier post procedure day. Infants in the surgical ligation group were more likely to experience vocal cord paralysis. There was no difference in neurodevelopmental outcomes between groups. Conclusion: Waiting for infants to achieve the appropriate size for percutaneous transcatheter closure of the PDA may lead to reduced short-term complications without increasing the risk of neurodevelopmental impairment. Health sciences/Diseases/Neurological disorders/Neurodevelopmental disorders Health sciences/Medical research/Outcomes research Health sciences/Diseases/Cardiovascular diseases INTRODUCTION The management of a patent ductus arteriosus (PDA) in extremely premature infants is a topic of paramount importance in neonatal care. Agreement on management, timing and mode of intervention remains controversial. Approximately 55% of extremely low birth weight infants (ELBW, infants born at < 1000g); 80% of infants born between 25–28 weeks gestation, and 90% of those born at 24 weeks ( 1 ) have a hemodynamically significant PDA (hsPDA) necessitating closure ( 2 ), to alleviate a clinically meaningful left-to-right shunt causing systemic hypoperfusion and pulmonary over circulation. ( 3 ) A hsPDA has been associated with an increased risk for prolonged ventilation, bronchopulmonary dysplasia (BPD) ( 4 ), necrotizing enterocolitis (NEC) ( 5 ), focal intestinal perforation, intraventricular hemorrhage (IVH) ( 6 ), and death ( 7 ), in addition to varying degrees of neurodevelopmental impairment (NDI) among ELBW infants. ( 8 ) Approaches to PDA closure among preterm infants has been the subject of controversy and debate for many years. ( 9 ) Surgical ligation remains the most prevalent interventional procedure and assures cessation of pulmonary over circulation and systemic hypoperfusion; however, immediate and long-term adverse effects do exist. Acutely, hemodynamic instability secondary to diminished low cardiac output and deterioration of global myocardial function, known as post-ligature syndrome (PLS) ( 10 ), may occur. PLS has been associated with an immediate decline in pulmonary compliance after ductal ligation ( 11 ) and results in alteration in cerebral perfusion ( 12 ) which may explain the association with long term impaired neurodevelopment. ( 13 ) The incidence of vocal cord paralysis (VCP), secondary to injury to the left recurrent laryngeal nerve by the clip or ligature ranges between 1 and 64%. Infants with VCP were more likely to develop BPD, to need prolonged mechanical ventilation and have been known to receive a slightly increased incidence of gastrostomy tube insertion. ( 14 ) Neurodevelopmental outcomes reported in premature infants with a hsPDA have been mixed. Some studies exhibited similar long-term outcomes in infants with a PDA regardless of the type of treatment ( 15 ) while other studies have shown worse NDI at 2–3 years of age in infants receiving either medical or surgical treatment. ( 16 ) Many investigators have correlated surgical ligation with negative neurodevelopmental outcome. Mechanisms which may be associated with NDI may include surgical effects, anesthesia effects or postoperative hemodynamic compromise affecting cerebral perfusion. ( 3 ) One study done in Sweden found that primary surgical ligation of a PDA was associated with increased risk for NDI at 6.5 years of age. ( 17 ) Another study in Canada found that surgical ligation of the PDA was associated with decreased mortality but increased NDI in early childhood. ( 3 ) ELBW infants are the most vulnerable to the morbidities of surgical ligation. Complications associated with surgical ligation have led to the consideration of other strategies for ductal closure among preterm infants. Percutaneous Transcatheter Closure (PTC) of the PDA is now a viable option in the ELBW population and is one of the safest cardiac interventional procedures. ( 18 ) Studies have demonstrated successful and safe transcatheter PDA closure. ( 19 ) In recent years, devices suitable to close the PDA for premature infants ≥ 700g at the time of procedure have become available. ( 20 ) It remains to be seen whether PTC represents a paradigm shift in PDA management that will result in improved short- and long-term outcomes, including less BPD, NEC/Spontaneous intestinal perforation, IVH or improved neurodevelopment. ( 21 ) The aim of this study is to examine the short- and long-term effects of PTC vs surgical closure. Our hypothesis is that PTC is associated with fewer short-term morbidities and has better neurodevelopmental outcomes compared to surgical ligation in infants born less than 29 weeks gestation. METHODS Trial Design This was an IRB approved single center observational retrospective-prospective case control study of premature infants born between 23–29 weeks gestation between the years 2015–2021 who underwent surgical ligation or PTC of the PDA. Variables were compared between the intervention groups, as well as with matched controls. Matched controls were infants in the same gestational age (GA) range with a PDA at the time of screening that didn’t receive medical or surgical treatment. Study Population Infants born between 23–29 weeks gestation who had an echocardiographically confirmed large PDA deemed to be hemodynamically significant requiring closure by the treating physician were eligible. Participants were further stratified into those who received surgical ligation or PTC. These patients were then followed at 2 to 3 years corrected gestational age (CGA) at the high risk Regional Neonatal Follow up Program associated with the NICU at Maria Fareri Children’s Hospital (MFCH) at Westchester Medical Center, Valhalla, NY, U.S. for neurodevelopmental (ND) evaluation. Exclusion criteria included infants with a hsPDA requiring only medical treatment, congenital heart disease, weight of less than 700g at time of PDA closure or chromosomal abnormalities. Interventions Standard practice for ELBW infants admitted to the MFCH NICU includes a screening echocardiogram performed on day of life (DOL) 3 to 5 to evaluate for the presence of a hsPDA. If a hsPDA is detected, Ibuprofen or Indomethacin will be prescribed. If 2 or more courses of COX inhibitors fail, and a hsPDA persists at the time of the repeat echocardiography, it is instrumentally closed. Prior to 2019, this was only achievable via surgical ligation. In 2019, PTC was introduced at this center and was an option for closure of a hsPDA for those infants 700g and above at the neonatologists’ discretion. Statistical analysis Data was collected from the patient's electronic medical records, entered into and analyzed using SPSS version 26 (IBM Corp, Armonk, NY, USA). Categorical variables were compared utilizing a Chi-square test; continuous variables were compared utilizing t-test or Mann-Whitney U test when appropriate. Statistical significance is considered to be a p value < 0.05. Results were presented as mean (SD) or n (%) as appropriate. This study was approved by the IRB of New York Medical College and WMC. Patient demographics and maternal characteristics Variables included maternal age, education level and race, multiple pregnancy, history of intrauterine growth restriction (IUGR), hypertension during pregnancy, preterm labor, preterm premature rupture of the membranes (PPROM, defined as membrane rupture before 37 weeks of gestation ( 22 )), delivery via C-section, maternal chorioamnionitis, and antenatal use of steroids, antibiotics and magnesium. Infant characteristics included GA at birth, gender, birth weight (BW), out born status and DOL at transfer. Outcome variables Outcomes assessed included history of NEC stage IIa and above ( 5 ), severe IVH defined as Papille Grade III or Grade IV IVH ( 6 ), retinopathy of prematurity (ROP) stage I and above ( 23 ), PLS defined by the need for hemodynamic support in the first 24 hours post ligation or transcatheter closure ( 24 ), VCP diagnosed by the lack of vocal cord movement on direct bronchoscopy or laryngoscopy, bronchopulmonary dysplasia defined as the requirement for supplemental oxygen or need positive pressure ventilation at 36 weeks postmenstrual age ( 4 ), transfer to chronic care facility, anthropometrics on discharge ( 25 ) and death. Neurodevelopmental outcomes Neurodevelopmental outcomes assessed between two and three years corrected age were determined by the Bayley Scales of Infant Development 3rd ed (BSID III). Composite scores for cognition, language, and motor function were recorded. Mean composite scores for each is 100 with a 15 point standard deviation (SD). Composite scores were further categorized to be normal (score of ≥ 85), mild impairment (70–84), moderate impairment (55–69) and severe impairment (< 55). Further receipt of early intervention services at the time of Bayley testing was reported. RESULTS Patient demographics and maternal characteristics A total of 48 infant charts were evaluated, 17 in the surgical ligation group, 16 in the PTC group (intervention groups), and 15 controls (Table 1 ). We observed that infants in the control group were delivered to younger mothers (28±3.5 (controls) vs. 34±6.4 (surgical ligation) and 31±6 years (PTC), p = 0.01) compared to the intervention groups. Infants in the surgical ligation group were more likely to be born to mothers with a diagnosis of PPROM (52.9% (surgical ligation) vs. 26.7% (controls) and 12.5% (PTC), p = 0.04). All mothers received at least 1 dose of antenatal steroids. Infants in the control and surgical ligation groups were more likely to be delivered to mothers who received a full course of antenatal steroids (66.7% (controls) and 58.8% (surgical ligation) vs. 13.3% (PTC), p = 0.01). Table 1 Patient demographics and maternal characteristics Surgical vs. PTC Controls vs. Surgical vs. PTC Surgical n = 17 PTC n = 16 p Controls n = 15 Surgical n = 17 PTC n = 16 p Maternal age years, mean (SD) 34 (±6.4) 31 (±6) 0.15 28 (±3.5) 34 (±6.4) 31 (±6) 0.01 Maternal race, n (%) Hispanic 5 (33.3%) 6 (40%) 0.46 3 (50%) 5 (33.3%) 6 (40%) 0.75 Caucasian 5 (33.3%) 3 (20%) 2 (33.3%) 5 (33.3%) 3 (20%) Indian 1 (6.7%) 0 (0%) 0 (0%) 1 (6.7%) 0 (0%) Asian 1 (6.7%) 0 (0%) 0 (0%) 1 (6.7%) 0 (0%) African-American 3 (20%) 6 (40%) 1 (16.7%) 3 (20%) 6 (40%) Multiple pregnancy, n (%) 9 (52.9%) 8 (50%) 0.86 5 (33.3%) 9 (52.9%) 8 (50%) 0.5 IUGR, n (%) 2 (11.8%) 4 (25%) 0.33 1 (6.7%) 2 (11.8%) 4 (25%) 0.32 Maternal Hypertension, n (%) 2 (11.8%) 2 (12.5%) 0.95 0 (0%) 2 (11.8%) 2 (12.5%) 0.37 Preterm labor, n (%) 13 (76.5%) 14 (87.5%) 0.41 13 (86.7%) 13 (76.5%) 14 (87.5%) 0.64 PPROM, n (%) 9 (52.9%) 2 (12.5%) 0.01 4 (26.7%) 9 (52.9%) 2 (12.5%) 0.04 C-section, n (%) 11 (64.7%) 11 (73.3%) 0.6 9 (60%) 11 (64.7%) 11 (73.3%) 0.74 Chorioamnionitis, n (%) 5 (29.4%) 1 (6.3%) 0.09 3 (20%) 5 (29.4%) 1 (6.3%) 0.23 Antibiotics, n (%) 12 (70.6%) 9 (64.3%) 0.71 10 (71.4%) 12 (70.6%) 9 (64.3%) 0.9 Magnesium, n (%) 12 (70.6%) 11 (73.3%) 0.86 11 (91.7%) 12 (70.6%) 11 (73.3%) 0.37 Full course of antenatal steroids, n (%) 10 (58.8%) 2 (13.3%) 0.008 10 (66.7%) 10 (58.8%) 2 (13.3%) < 0.01 Perinatal characteristics There was a significant difference in GA and BW. Infants in the control group were born at a later GA (26.5 ±1.7 (controls) vs. 24.8±1.6 (surgical ligation) and 25.2±1.6 (PTC), p = 0.02) and higher BW (1029±228.8 (controls) vs. 727.6±222.6 (surgical ligation) and 731.88±200 (PTC), p < 0.01) compared to the intervention groups (Table 2 ). When surgical and PTC groups were compared, there was no statistical difference in GA or BW. Table 2 Perinatal characteristics Surgical vs. PTC Controls vs. Surgical vs. PTC Surgical n = 17 PTC n = 16 p Controls n = 15 Surgical n = 17 PTC n = 16 p Gestational age, week, mean (SD) 24.8 (±1.6) 25.2 (± 1.6) 0.58 26.5 (±1.7) 24.8 (±1.6) 25.2 (1.6) 0.02 Male gender, n (%) 13 (76.5%) 7 (43.8%) 0.06 11 (73.3%) 13 (76.5%) 7 (43.8%) 0.1 Birth weight, g, mean (SD) 727.6 (±222.6) 731.88 (±200) 0.96 1029 (±228.8) 727.6 (±222.6) 731.88 (±200) < 0.01 Outborn, n, (%) 3 (17.6%) 6 (37.5%) 0.2 3 (20%) 3 (17.6%) 6 (37.5%) 0.36 DOL at transfer, day, mean (SD) 1 0 (±0) 21.8 (±20.7) 0.12 6.7 (±11.5) 0 (±0) 21.8 (±20.7) 0.18 Any surfactant, n (%) 15 (88.22%) 16 (100%) 0.16 14 (93.3%) 15 (88.22%) 16 (100%) 0.38 Culture proven infection ever 7 (41.2%) 9 (56.3%) 0.39 1 (6.7%) 7 (41.2%) 9 (56.3%) 0.01 NEC stage IIa and above ever 3 (17.6%) 3 (18.8%) 0.93 2 (13.3%) 3 (17.6%) 3 (18.8%) 0.91 Severe IVH ever 2 (11.8%) 3 (18.8%) 0.58 2 (13.3%) 2 (11.8%) 3 (18.8%) 0.84 1 Based on total out born infants There were 3 (17.6%) out born infants in the surgical group, and 6 (37.5%) in the PTC group. There was no difference in out born status between groups, however there was a trend for the transcatheter closure patients to be more likely out born, and to be transferred at a later DOL. Infants in the surgical and PTC groups were more likely to have developed any culture proven infection, compared to the controls (6.7% (controls) vs. 41.2% (surgical ligation) and 56.3% (PTC), p = 0.01). However, most of these culture proven infections occurred prior to the procedure (35.3% (surgical) and 43.8% (PTC), p = 0.62), as opposed to after the procedure (23.5% (surgical) and 18.8% (PTC), p = 0.74). Morbidities before intervention among intervention groups When comparing only those infants in the two procedural intervention groups, the PTC group had an older CGA (29±3 vs. 33±5.2, p = 0.01), greater weight (1053±405.5 vs. 1615±926.7, p = 0.03) and later DOL (30±18.5 vs. 54±34.4, p = 0.02) at the time of the procedure (Table 3 ). Infants in the surgical group had a higher creatinine prior to their procedure (0.71±0.31, 0.48±0.15, p = 0.01). There was no difference in type of ventilatory support used before the procedure between groups. Table 3 Morbidities before and after intervention Surgical n = 17 PTC n = 16 p Morbidities before intervention CGA 1 at intervention, week, mean (SD) 29 (±3) 33 (±5.2) 0.01 Weight 1 at intervention, g, mean (SD) 1053 (±405.5) 1615 (±926.7) 0.03 DOL 1 at intervention, day, mean (SD) 30 (±18.5) 54 (±34.4) 0.02 Culture proven infection, n (%) 6 (35.3%) 7 (43.8%) 0.62 Medical treatment for PDA, n (%) None 1 (5.9%) 2 (12.5%) 0.75 1 course 8 (47.1%) 6 (37.5%) 2 courses 8 (47.1%) 8 (50%) NEC stage IIa and above, n (%) 1 (5.9%) 3 (18.8%) 0.26 Severe IVH, n (%) 2 (11.8%) 3 (18.8%) 0.58 Mechanical ventilation, n (%) Non-invasive 3 (17.6%) 4 (25%) 0.61 Invasive 14 (82.4%) 12 (75%) Type of invasive ventilator 2 Conventional 5 (35.7%) 7 (58.3%) 0.25 High frequency 9 (64.3%) 5 (41.7%) Hct before procedure 34.2 (±4.3) 36.4 (±3.6) 0.12 Hct after procedure 34.4 (±4) 33.8 (±3.5) 0.63 Cr before procedure, mean (SD) 0.71 (±0.31) 0.48 (±0.15) 0.01 Cr after procedure, mean (SD) 0.73 (±0.41) 0.46 (±0.14) 0.02 Cr difference before and after procedure, mean (SD) 0.02 (±0.17) -0.01 (±0.07) 0.54 Morbidities after intervention Type of invasive ventilator, n (%) Conventional 6 (35.3%) 11 (68.8%) 0.055 High frequency 11 (64.7%) 5 (31.3%) Days on mechanical ventilation, mean (SD) 18.6 (±29.2) 25.7 (±42.7) 0.57 Achieved RA before discharge, n (%) 10 (58.8%) 9 (56.3%) 0.88 POD achievement of RA, day, mean (SD) 3 79.3 (±23.1) 45.9 (±26.6) < 0.014 DOL achievement of RA, day, mean (SD) 3 106.2 (±24.6) 85.1 (±35.5) 0.11 CGA achievement of RA, week, mean (SD) 3 40.1 (±3.1) 38.5 (±2.5) 0.24 Vasopressors, n (%) 0 0 - Culture proven infection, n (%) 4 (23.5%) 3 (18.8%) 0.74 NEC stage IIa and above, n (%) 2 (11.8%) 0 (0%) 0.16 POD initiation of enteral feeds, mean (SD) 4.5 (±5) 1.4 (±1) 0.02 POD achievement of full enteral feeds, day, mean (SD) 10.7 (±7.6) 7.1 (±8) 0.2 Achieved full oral feeds before discharge, n (%) 13 (76.5%) 13 (81.3%) 0.74 POD achievement of full oral feeds, day, mean (SD) 4 76 (±32.8) 61 (±26.6) 0.21 DOL achievement of full oral feeds, day, mean (SD) 4 99.3 (±42.7) 113.8 (±34.7) 0.35 CGA achievement of full oral feeds, week, mean (SD) 4 40.5 (±3.5) 41.7 (±4.6) 0.45 1 At intervention 2 Based on 26 infants on invasive mechanical ventilation 3 Based on infants who achieved RA status before discharge 4 Based on infants who achieved full oral feeds before discharge Characteristics post intervention among intervention groups Infants in the surgical group were more likely to require treatment with a high frequency ventilator post procedure, although this trend did not reach significance (64.7% v. 31.3%, p = 0.055) (Table 4 ). Creatinine level after intervention was higher in the surgical ligation group (0.73±0.41 vs. 0.46±0.14, p = 0.02), however, there was no difference in change in creatinine level before and after the procedure (0.02±0.17 vs. -0.01±0.07, p = 0.54) between interventional groups. Table 4 Morbidities on discharge Surgical vs. PTC Controls vs. Surgical vs. PTC Surgical n = 17 PTC n = 16 p Controls n = 15 Surgical n = 17 PTC n = 16 p ROP, n (%) 12 (70.6%) 12 (75%) 0.78 1 (6.7%) 12 (70.6%) 12 (75%) < 0.01 ROP requiring treatment 3 (17.6%) 3 (18.8%) 0.94 0 (0%) 3 (17.6%) 3 (18.8%) 0.89 Severe IVH*, n (%) 2 (11.8%) 3 (18.8%) 0.58 2 (13.3%) 2 (11.8%) 2 (18.8%) 0.84 Vocal cord paralysis, n (%) 8 (41.7%) 2 (12.5%) 0.03 - - - - BPD, n (%) 16 (94.1%) 15 (93.8%) 0.97 4 (26.7%) 16 (94.1%) 15 (93.8%) < 0.01 Tracheostomy 1 (5.9%) 2 (12.5%) 0.51 0 (0%) 1 (5.9%) 2 (12.5%) 0.36 G-tube 2 (11.8%) 2 (12.5%) 0.95 0 (0%) 2 (11.8%) 2 (12.5%) 0.37 Disposition on discharge Discharge home 14 (82.4%) 12 (75%) 0.61 12 (80%) 14 (82.4%) 12 (75%) 0.87 Discharge home on oxygen 6 (35.3%) 5 (31.3%) 0.81 2 (13.3%) 6 (35.3%) 5 (31.3%) 0.34 Transfer to chronic care facility 2 (11.8%) 2 (12.5%) 0.95 0 (0%) 2 (11.8%) 2 (12.5%) 0.37 Discharge on oxygen 7 (41.2%) 7 (43.8%) 0.88 2 (13.3%) 7 (41.2%) 7 (43.8%) 0.14 Transfer to lower level NICU 1 (5.9%) 1 (6.3%) 0.97 3 (20%) 1 (5.9%) 1 (6.3%) 0.34 Mortality 0 (0%) 1 (6.3%) 0.3 0 (0%) 0 (0%) 1 (6.3%) 0.36 DOL at discharge, day (SD) 138.5 (±41.8) 133.1 (±41.8) 0.71 77.8 (±27.6) 138.5 (±41.8) 133.1 (±41.8) < 0.01 CGA at discharge, week (SD) 44.8 (±5.1) 44.3 (±5.4) 0.29 37.8 (±3.5) 44.8 (±5.1) 44.3 (±5.4) < 0.01 LOS, day (SD) 138.5 (±41.8) 126.6 (±44.7) 0.46 76.9 (±30.4) 138.5 (±41.8) 126.6 (±44.7) < 0.01 Weight percentile (SD) 28.3 (±23.3) 22.1 (±17.4) 0.4 42.3 (±23.6) 28.3 (±23.3) 22.1 (±17.4) 0.04 Head circumference percentile (SD) 36.2 (±28.4) 35.4 (±23.7) 0.94 54.3 (±31.4) 36.2 (±28.4) 35.4 (±23.7) 0.12 Infants in the PTC group initiated enteral feeds post procedure earlier compared to the surgical group (POD 1.4±1 vs. 4.5±5, p = 0.02). Infants in the PTC group reached full enteral feeds sooner on POD 7, whereas infants in the surgical group did so on POD 10, though not reaching statistical significance. Some patients in each intervention group were not able to reach full oral feeds or RA prior to discharge which occurred at similar rates between intervention groups. Of those who achieved RA before discharge, infants in the PTC group did so at an earlier post procedure day compared to the surgical group (POD 79.3±23.1 (surgical ligation) vs. 45.9±6.6 (PTC), p < 0.01). Infants in the PTC group reached RA status at an earlier DOL (85.1±35.5 (PTC) vs. 106.2±24.6 (surgical ligation), p = 0.11) and CGA (38.5±2.5 (PTC) vs. 40.1±3.1 (surgical ligation), p = 0.24). This was a difference by 2 to 3 weeks, not reaching, statistical significance however clinically is impactful and was accomplished despite procedural intervention occurring at a later CGA and DOL in the PTC group. Morbidities at discharge intervention and control groups Infants in the surgical and PTC groups were more likely to have developed ROP and BPD, compared to controls (6.7% (controls) vs 70.6% (surgical ligation) and 75% (PTC), p < 0.01) (Table 5 ). When comparing the intervention groups to one another, there was no difference in rates of ROP or BPD. Surgical ligation was more likely to be associated with VCP. (41.7% vs. 12.5%, p = 0.03). On further analysis, we found that infants with VCP reached RA status at a later POD (88±22.8 vs. 55.6±29, p = 0.038), compared to infants without VCP. Table 5 Neurodevelopmental outcomes Surgical vs. PTC Controls vs. Surgical vs. PTC Surgical n = 16 PTC n = 12 p Controls n = 15 Surgical n = 16 PTC n = 12 p NDI according to Bayley cognitive composite score, n (%) Normal > 85 11 (68.8%) 8 (66.7%) 0.99 12 (80%) 11 (68.8%) 8 (66.7%) 0.87 Mild 70–84 3 (18.8%) 2 (16.7%) 3 (20%) 3 (18.8%) 2 (16.7%) Moderate 55–69 1 (6.3%) 1 (8.3%) 0 (0%) 1 (6.3%) 1 (8.3%) Severe 85 7 (43.8%) 7 (58.3%) 0.55 9 (60%) 7 (43.8%) 7 (58.3%) 0.85 Mild 70–84 3 (18.8%) 1 (8.3%%) 2 (13.3%) 3 (18.8%) 1 (8.3%%) Moderate 55–69 5 (31.3%) 2 (16.7%) 3 (20%) 5 (31.3%) 2 (16.7%) Severe 85 8 (50%) 8 (66.7%) 0.54 13 (86.7%) 8 (50%) 8 (66.7%) 0.29 Mild 70–84 5 (31.3%) 1 (8.3%) 1 (6.7%) 5 (31.3%) 1 (8.3%) Moderate 55–69 1 (6.3%) 1 (8.3%) 1 (6.7%) 1 (6.3%) 1 (8.3%) Severe < 54 2 (12.5%) 2 (16.7%) 0 (0%) 2 (12.5%) 2 (16.7%) Early intervention 14 (87.5%) 10 (83.3%) 0.76 8 (53.3%) 14 (87.5%) 10 (83.3%) 0.07 Physical therapy 9 (56.3%) 8 (66.7%) 0.58 5 (33.3%) 9 (56.3%) 8 (66.7%) 0.12 Occupational therapy 11 (68.8%) 8 (66.7%) 0.91 5 (33.3%) 11 (68.8%) 8 (66.7%) 0.09 Speech therapy 13 (81.3%) 9 (81.8%) 0.97 8 (53.3%) 13 (81.3%) 9 (81.8%) 0.15 Special educator 11 (68.8%) 5 (45.5%) 0.23 3 (20%) 11 (68.8%) 5 (45.5%) 0.02 Infants in the intervention groups were discharged at a later DOL (77.8±27.6 (controls) vs. 138.5±41.8 (surgical ligation) and 133.1±41.8 (PTC), p < 0.01), CGA (37.8±3.5 (controls) vs. 44.8±5.1 (surgical ligation) and 44.3±5.4 (PTC), p < 0.01), and had a longer LOS compared to the control group. No difference was seen when comparing these variables between the two intervention groups. Infants in the control group were discharged at a greater weight percentile compared to either of the two intervention groups (42.3±23.6 (controls) vs. 28.3±23.3 (surgical ligation) and 22.1±17.4 (PTC), p = 0.04), while no difference was seen between the two intervention groups (28.3±23.3 vs. 22.1±17.4, p = 0.4). (Table 5 ) Neurodevelopmental outcomes Of the 48 infants included in the study, 42 were followed at The Regional Neonatal Follow Up Program affiliated with Maria Fareri Children’s Hospital. All controls were followed. One patient in the surgical group moved out of the country. Two patients in the PTC group moved out of state, 1 was unable to be reached and 1 died before discharge due to complications from BPD. Overall, 89.4% of the patients were followed. CGA at assessment was between 22 to 30 months in all the study population, which was not significant both when comparing intervention groups with controls (p = 0.213) and when comparing only intervention groups (p = 0.34). There was no difference in NDI between groups. Both intervention groups were more likely to have a special educator, compared to controls. DISCUSSION This study represents a novel contribution to the literature providing insight into short-term morbidities, outcomes at discharge, and long-term neurodevelopmental outcomes among a cohort of premature infants treated for a hsPDA who underwent surgical ligation or PTC, compared with infants with a PDA for which no intervention occurred. Our primary objective was to evaluate whether PTC in the 23-29-week age group had better short-term outcomes and better neurodevelopmental outcomes than their surgical counterparts. Therapeutic options for a hsPDA include supportive treatment, pharmacological therapy, and surgical ligation, all of which have their advantages, limitations and consequences. ( 8 ) Researchers have found that infants with a medically and/or surgically treated hsPDA had more comorbidities at discharge compared to infants treated conservatively. Speculation remains however that this correlation is predicated upon the medical or surgical group being sicker at baseline. ( 15 ) Furthermore, the burning question persists: Is it truly worth the repercussions to eliminate a hsPDA at an earlier age in this particularly fragile patient group? We chose the most vulnerable group of patients to study, infants between 23–29 weeks, because they are the group who have the most morbidities. Previous studies show the association between GA, BW and the occurrence of PDA. A meta-analysis performed by Liu et al demonstrated that a lower GA and lower BW are associated with the development of a hsPDA. ( 26 ) In our study, infants in the intervention groups who developed a hsPDA necessitating medical and/or surgical treatment were born at a younger GA and smaller BW, compared to the control group. These infants are therefore inherently at increased risk for morbidities associated with prematurity. Looking at our study group of ELBW infants, infants in both intervention groups had similar gestational age and weight at birth. Patients in the PTC group were older and larger at the time of the procedure compared to the surgical ligation group. This may be related to the fact that nearly 38% of patients who received PTC were out born. We found that those in the surgically ligated group had higher creatinine levels both before and after the intervention as compared to the PTC group. Lenoir et al. did a similar study and found that creatinine levels before procedure were also higher in the surgical group. ( 27 ) Other studies have not found this type of an association of hsPDA with AKI (acute kidney injury). ( 28 ) Low birth weight and early GA have been associated with AKI related to the decreased number of nephrons and GFR in these patients. ( 29 ) The fact that the surgical group in our cohort was of smaller size and more premature at the time of intervention compared to the PTC group may explain the above findings. Elevated creatinine levels demonstrated in the surgical ligation group may be more a function of a paucity of nephrons and arrest of kidney development in a younger and smaller population rather than due to the prolonged effects of a hsPDA. The procedural intervention itself, whether surgical or PTC, did not affect the change in creatinine level between the two groups. We found that the PTC group reached RA status 2 to 3 weeks earlier than the surgical group post procedure, which is likely secondary to being older at the time of procedure. Further, infants in the surgical group, who were also younger and smaller at the time of procedure, were more likely to require high frequency ventilation after their procedure. Neither of these conditions reached statistical significance, however, these negative effects on respiratory outcomes can be considered clinically significant. These findings are similar to others who have also noted this improved time to wean respiratory support in the transcatheter group. ( 9 , 32 ) These findings may be reflective of the need to deflate the lung for the procedure, and then re-inflate the lung after the procedure with the associated inflammatory effects ( 33 , 34 ). Patients in the surgical group also took longer to initiate enteral feeds post procedure. Previous research has studied the benefits of earlier initiation of enteral feeds after a surgical intervention, which may include improved weight gain, shorter duration of parenteral nutrition, decreased feeding intolerance and decreased length of stay. ( 35 – 37 ) The presence of a hsPDA has been long associated with higher rates of BPD, IVH, NEC and ROP.( 38 ) The rates of these significant NICU morbidities were higher in both intervention groups compared to the control group, however, when comparing the two intervention groups to one another, there was no difference. Likewise, there were no distinctions in terms of DOL, CGA at discharge, or length of stay (LOS) between the two intervention groups. These findings suggest that the early implementation of surgical intervention at a lower weight and earlier gestational age for hsPDA management, aimed at enhancing clinical outcomes, does not result in a substantial reduction in these targeted NICU morbidities. Vocal cord paralysis has long been associated with surgical ligation of the PDA. Benjamin et al. did a retrospective study to determine the relationship between left vocal cord paralysis (LVCP) and respiratory morbidities, feeding and growth difficulties and neurodevelopmental impairment at 18 to 22-month follow-up. ( 39 ) They found a 40% rate of LVCP in their population, which was similar to the 41.7% rate of LVCP in the surgical ligation group found in this study. This didn’t result in a higher need for tracheostomy or g-tube between the two intervention groups. However, we did see that infants with VCP, most of whom were in the surgical group, reached RA status at later POD. It could be speculated that the presence of VCP as a consequence of surgical ligation of the PDA could impact the infants need for respiratory support. Previous research has hinted at a link between extended hsPDA exposure and adverse outcomes, such as BPD and deteriorating NDI. ( 40 ) We found no difference in NDI between groups. Infants within the PTC group experienced a longer hsPDA exposure, owing to their later gestational age at the time of intervention. Despite this prolonged exposure, our data did not point to an elevated risk of concurrent comorbidities. This finding supports the notion that early interventional closure of a hsPDA may not lead to a reduction in associated comorbidities. In conclusion, considering the morbidities associated with surgical ligation, our findings strongly advocate for PTC as an alternative for PDA closure in ELBW premature infants. Despite the fact that infants in the PTC group had an older DOL and CGA, and a higher weight at the time of procedure, there was no increased incidence of severe morbidities such as severe IVH, ROP, BPD, NEC, sepsis, prolonged LOS or worse NDI as a result of prolonged exposure to a hsPDA. The evidence suggests that delaying the intervention until infants reach the appropriate size criteria for transcatheter closure could potentially lead to a reduction in short-term comorbidities and a quicker recovery period after the procedure without increasing the risk for acute NICU morbidities or future NDI. Limitations: We acknowledge that our sample size was small. As more procedures are done, we will have the opportunity to investigate further the specific details which influence infant outcomes. This was also a retrospective prospective study, thus, the population studied was not randomized. As a result, differing management styles of the neonatologists over time may introduce a bias and a difficulty in designating a control group Anesthesia exposure has been associated with worse NDI in the preterm population. ( 41 ) This information could not be retrieved from the medical records for the current study, hence impact of anesthesia exposure in this population could not be assessed. A total of 1 patient in the surgical group, and 3 in the PTC group were lost to follow up. However, a follow up rate 89.4% was achieved. Although our findings did not reveal a difference in NDI between the groups, it is imperative to acknowledge the limitations of our smaller sample size, which may have obscured potentially meaningful associations. Finally, part of our population was evaluated during the COVID-19 pandemic. A proportion of our population was receiving some type of therapy through the Early Intervention program at the time of Bayley evaluation. It is well known that during the COVID-19 pandemic, many healthcare facilities and therapy centers were forced to limit in-person services due to safety concerns and lockdown measures. ( 42 , 43 ) This disruption could have potential implications for access to speech, occupational, and physical therapy services for former preterm infants, and may have impacted their neurodevelopment. Declarations Acknowledgements: We thank Westchester Medical Center and the High Risk Regional Neonatal Follow up Program associated with the NICU at Maria Fareri Children’s Hospital (MFCH) at Westchester Medical Center who allowed us to collect data for our study. Conflicts of interest The authors declare that they have no conflict of interest. Author contributions MCF drafted the manuscript and performed the initial analysis. JK assisted with analysis, reviewed drafts of manuscripts and made substantial contributions to draft. JG contributed to the analysis plan and reviewed drafts of manuscripts and made contributions to draft. AR conceived the original project, scientific design, analysis plan, and reviewed and made contributions to multiple drafts of the paper. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. Funding None declared. References Su BH, Lin HY, Chiu HY, Tsai ML, Chen YT, Lu IC. Therapeutic strategy of patent ductus arteriosus in extremely preterm infants. Vol. 61, Pediatrics and Neonatology. Elsevier (Singapore) Pte Ltd; 2020. p. 133–41. H Al Nemri AM. Review Article Patent ductus arteriosus in preterm infant: Basic pathology and when to treat [Internet]. Vol. 14, SUDANESE JOURNAL OF PAEDIATRICS. 2014. Available from: http://www.sudanjp.org Weisz DE, More K, McNamara PJ, Shah PS. PDA ligation and health outcomes: A meta-analysis. Vol. 133, Pediatrics. American Academy of Pediatrics; 2014. McEvoy CT, Jain L, Schmidt B, Abman S, Bancalari E, Aschner JL. Bronchopulmonary Dysplasia: NHLBI Workshop on the Primary Prevention of Chronic Lung Diseases. Ann Am Thorac Soc [Internet]. 2014;11(Supplement 3):S146–53. Available from: https://doi.org/10.1513/AnnalsATS.201312-424LD BELL MJ, TERNBERG JL, FEIGIN RD, KEATING JP, MARSHALL R, BARTON L, et al. Neonatal Necrotizing Enterocolitis. Therapeutic Decisions Based upon Clinical Staging. Ann Surg. 1978;187(1). Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: A study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92(4). Hamrick SEG, Sallmon H, Rose AT, Porras D, Shelton EL, Reese J, et al. Patent Ductus Arteriosus of the Preterm Infant. Pediatrics [Internet]. 2020;146(5):e20201209. Available from: https://doi.org/10.1542/peds.2020-1209 Mitchell CC, Rivera BK, Cooper JN, Smith C V, Berman DP, Slaughter JL, et al. Percutaneous closure of the patent ductus arteriosus: opportunities moving forward. Congenit Heart Dis [Internet]. 2019;14(1):95–9. Available from: https://onlinelibrary.wiley.com/doi/abs/ 10.1111/chd.12704 Rodríguez Ogando A, Planelles Asensio I, de la Blanca ARS, Ballesteros Tejerizo F, Sánchez Luna M, Gil Jaurena JM, et al. Surgical Ligation Versus Percutaneous Closure of Patent Ductus Arteriosus in Very Low-Weight Preterm Infants: Which are the Real Benefits of the Percutaneous Approach? Pediatr Cardiol. 2018;39(2):398–410. McNamara PJ, Stewart L, Shivananda SP, Stephens D, Sehgal A. Patent ductus arteriosus ligation is associated with impaired left ventricular systolic performance in premature infants weighing less than 1000 g. J Thorac Cardiovasc Surg [Internet]. 2010;140(1):150–7. Available from: https://doi.org/10.1016/j.jtcvs.2010.01.011 Teixeira LS, Shivananda SP, Stephens D, Van Arsdell G, McNamara PJ. Postoperative cardiorespiratory instability following ligation of the preterm ductus arteriosus is related to early need for intervention. Journal of Perinatology [Internet]. 2008;28(12):803–10. 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Retrospective comparison of death or neurodevelopmental outcomes in extremely low birth weight preterm infants following different management options of haemodynamically significant patent ductus arteriosus. BMC Pediatr. 2021;21(1). Janz-Robinson EM, Badawi N, Walker K, Bajuk B, Abdel-Latif ME, Bowen J, et al. Neurodevelopmental Outcomes of Premature Infants Treated for Patent Ductus Arteriosus: A Population-Based Cohort Study. Journal of Pediatrics. 2015;167(5):1025–1032.e3. Gudmundsdottir A, Broström L, Skiöld B, Källén K, Serenius F, Norman M, et al. The type and timing of patent ductus arteriosus treatment was associated with neurodevelopment when extremely preterm infants reached 6.5 years. Acta Paediatrica, International Journal of Paediatrics. 2021;110(2):510–20. Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith C V., et al. Percutaneous patent ductus arteriosus (PDA) closure in very preterm infants: Feasibility and complications. J Am Heart Assoc. 2016;5(2). Narin N, Pamukçu Ö, Baykan A, Argun M, Özyurt A, Bayram A, et al. Transcatheter closure of PDA in premature babies less than 2 kg. Anatol J Cardiol. 2017;17(2):147–53. Sathanandam SK, Gutfinger D, O’Brien L, Forbes TJ, Gillespie MJ, Berman DP, et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥ 700 grams. Catheterization and Cardiovascular Interventions [Internet]. 2020;96(6):1266–76. Available from: https://doi.org/10.1002/ccd.28973 Vali P, Lakshminrusimha S, Pelech A, Underwood M, Ing F. Patent ductus arteriosus in preterm infants: is early transcatheter closure a paradigm shift? Journal of Perinatology [Internet]. 2019;39(11):1449–61. Available from: https://doi.org/10.1038/s41372-019-0506-7 Dayal S, Hong. PL. StatPearls [Internet]. 2023 [cited 2023 Jul 23]. Premature Rupture of Membranes. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532888/ Prematurity* C of R of. The International Classification of Retinopathy of Prematurity Revisited. Archives of Ophthalmology [Internet]. 2005;123(7):991–9. Available from: https://doi.org/10.1001/archopht.123.7.991 Serrano RM, Madison M, Lorant D, Hoyer M, Alexy R. Comparison of ‘post-patent ductus arteriosus ligation syndrome’ in premature infants after surgical ligation vs. percutaneous closure. Journal of Perinatology. 2020;40(2):324–9. Fenton TR. A new growth chart for preterm babies: Babson and Benda’s chart updated with recent data and a new format. BMC Pediatr [Internet]. 2003;3(1):13. Available from: https://doi.org/10.1186/1471-2431-3-13 Liu C, Zhu X, Li D, Shi Y. Related Factors of Patent Ductus Arteriosus in Preterm Infants: A Systematic Review and Meta-Analysis. Front Pediatr. 2021;8. Lenoir M, Wanert C, Bonnet D, Méot M, Tosello B, Fouilloux V, et al. Anterior Minithoracotomy vs. Transcatheter Closure of Patent Ductus Arteriosus in Very Preterm Infants. Front Pediatr. 2021;9. Velazquez DM, Reidy KJ, Sharma M, Kim M, Vega M, Havranek T. The effect of hemodynamically significant patent ductus arteriosus on acute kidney injury and systemic hypertension in extremely low gestational age newborns. The Journal of Maternal-Fetal & Neonatal Medicine [Internet]. 2019;32(19):3209–14. Available from: https://doi.org/10.1080/14767058.2018.1460349 Nagaraj N, Berwal PK, Srinivas A, Berwal A. A study of acute kidney injury in hospitalized preterm neonates in NICU. J Neonatal Perinatal Med. 2016;9:417–21. Sari IM, Adisasmita AC, Prasetyo S, Amelia D, Purnamasari R. Effect of premature rupture of membranes on preterm labor: a case-control study in Cilegon, Indonesia. Epidemiol Health. 2020;42. Kachikis A, Walker CL, McAdams RM, Gyamfi-Bannerman C, Adams Waldorf KM. Phenotypic Overlap in Neonatal Respiratory Morbidity Following Preterm Premature Rupture of Membranes Versus Spontaneous Preterm Labor. J Matern Fetal Neonatal Med. 2021; Regan W, Benbrik N, Sharma SR, Auriau J, Bouvaist H, Bautista-Rodriguez C, et al. Improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus. Int J Cardiol. 2020;311:22–7. Weldetsadik AY, Demisse AG. Re-Expansion Pulmonary Edema in Children - A Rare Complication After Pneumothorax Drainage: A Case Report. Int Med Case Rep J [Internet]. 2022;15:239–43. Available from: https://www.tandfonline.com/doi/abs/10.2147/ IMCRJ.S364881 Funakoshi T, Ishibe Y, Okazaki N, Miura K, Liu R, Nagai S, et al. Effect of re-expansion after short-period lung collapse on pulmonary capillary permeability and pro-inflammatory cytokine gene expression in isolated rabbit lungs. Br J Anaesth [Internet]. 2004;92(4):558–63. Available from: https://doi.org/10.1093/bja/aeh101 Ghorbani M, Rezaeian A, Khademi G, Shojaeian R, Jafari SA. Effects of Early Feeding Support on the Postoperative Weight Gain Status of Infants with Esophageal Atresia. Evidence Based Care [Internet]. 2016;6(2):67–74. Available from: https://ebcj.mums.ac.ir/article_7327.html Thompson PJ, Walker K, Halliday R, Holland AJA, Trivedi A. Early Enteral Feeding Following Repair of Gastroschisis is Associated with Shorter Length of Admission and Better Nutritional Outcomes. J Clin Neonatol [Internet]. 2017;6(4). Available from: https://journals.lww.com/jocn/fulltext/2017/06040/early_enteral_feeding_following_repair_of.4.aspx Du N, Cui Y, Xie W, Yin C, Gong C, Chen X. Application effect of initiation of enteral nutrition at different time periods after surgery in neonates with complex congenital heart disease: A retrospective analysis. Medicine [Internet]. 2021;100(1). Available from: https://journals.lww.com/md-journal/fulltext/2021/01080/application_effect_of_initiation_of_enteral.70.aspx Terrin G, Di Chiara M, Boscarino G, Metrangolo V, Faccioli F, Onestà E, et al. Morbidity associated with patent ductus arteriosus in preterm newborns: a retrospective case-control study. Ital J Pediatr [Internet]. 2021;47(1):9. Available from: https://doi.org/10.1186/s13052-021-00956-2 Benjamin JR, Smith PB, Cotten CM, Jaggers J, Goldstein RF, Malcolm WF. Long-term morbidities associated with vocal cord paralysis after surgical closure of a patent ductus arteriosus in extremely low birth weight infants. Journal of Perinatology. 2010;30(6):408–13. Youn YA, Seo YM, Yum SK, Sung IK. Patent ductus arteriosus ligation on neurodevelopmental outcomes at corrected 2 years. Ital J Pediatr. 2019;45(1). Walsh BH, Paul RA, Inder TE, Shimony JS, Smyser CD, Rogers CE. Surgery requiring general anesthesia in preterm infants is associated with altered brain volumes at term equivalent age and neurodevelopmental impairment. Pediatr Res [Internet]. 2021;89(5):1200–7. Available from: https://doi.org/10.1038/s41390-020-1030-3 Kronberg J, Tierney E, Wallisch A, Little LM. Early Intervention Service Delivery via Telehealth During COVID-19: A Research-Practice Partnership. Int J Telerehabil. 2021;13(1). DE LEON IC, Philipps J, Yoegel M, Byrnes J, Kase JS. COMPARISON OF GOAL ACHIEVEMENT WHEN TRANSITIONING FROM IN-PERSON THERAPY TO TELETHERAPY IN WESTCHESTER COUNTY EARLY INTERVENTION PROGRAM DUE TO THE COVID-19 PANDEMIC. Int J Telerehabil. 2022;14(1). Additional Declarations There is NO conflict of interest to disclose. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3851197","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":267383956,"identity":"ac829c57-dc9a-4b9a-9faa-e6a63813bed8","order_by":0,"name":"Maria Fernandez Ramos","email":"data:image/png;base64,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","orcid":"","institution":"Maria Fareri Children's Hospital/Westchester Medical Center","correspondingAuthor":true,"prefix":"","firstName":"Maria","middleName":"Fernandez","lastName":"Ramos","suffix":""},{"id":267383957,"identity":"67e29e31-5421-49f6-949b-021b974fe55a","order_by":1,"name":"Amy Reichlin","email":"","orcid":"","institution":"Maria Fareri Children's Hospital/Westchester Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Amy","middleName":"","lastName":"Reichlin","suffix":""},{"id":267383958,"identity":"7f2cf38f-c15e-4a6e-9bfb-8339a854e65f","order_by":2,"name":"Jordan Kase","email":"","orcid":"","institution":"Maria Fareri Children’s Hospital at Westchester Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Jordan","middleName":"","lastName":"Kase","suffix":""},{"id":267383959,"identity":"26b45de9-d13b-4eda-b4af-7ff9fd77c1cf","order_by":3,"name":"Joseph Giamelli","email":"","orcid":"","institution":"Maria Fareri Children's Hospital/Westchester Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Joseph","middleName":"","lastName":"Giamelli","suffix":""}],"badges":[],"createdAt":"2024-01-10 18:45:49","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3851197/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3851197/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41372-024-02019-w","type":"published","date":"2024-06-03T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":57710284,"identity":"d86aadf3-d682-4840-95fa-d1c512b0eb00","added_by":"auto","created_at":"2024-06-04 15:48:21","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":994788,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3851197/v1/6875e8c9-be29-4d45-9598-d1c3e6ded5af.pdf"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThe management of a patent ductus arteriosus (PDA) in extremely premature infants is a topic of paramount importance in neonatal care. Agreement on management, timing and mode of intervention remains controversial. Approximately 55% of extremely low birth weight infants (ELBW, infants born at \u0026lt;\u0026thinsp;1000g); 80% of infants born between 25\u0026ndash;28 weeks gestation, and 90% of those born at 24 weeks (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) have a hemodynamically significant PDA (hsPDA) necessitating closure (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e), to alleviate a clinically meaningful left-to-right shunt causing systemic hypoperfusion and pulmonary over circulation. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) A hsPDA has been associated with an increased risk for prolonged ventilation, bronchopulmonary dysplasia (BPD) (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), necrotizing enterocolitis (NEC) (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), focal intestinal perforation, intraventricular hemorrhage (IVH) (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e), and death (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), in addition to varying degrees of neurodevelopmental impairment (NDI) among ELBW infants. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eApproaches to PDA closure among preterm infants has been the subject of controversy and debate for many years. (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) Surgical ligation remains the most prevalent interventional procedure and assures cessation of pulmonary over circulation and systemic hypoperfusion; however, immediate and long-term adverse effects do exist. Acutely, hemodynamic instability secondary to diminished low cardiac output and deterioration of global myocardial function, known as post-ligature syndrome (PLS) (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e), may occur. PLS has been associated with an immediate decline in pulmonary compliance after ductal ligation (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) and results in alteration in cerebral perfusion (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) which may explain the association with long term impaired neurodevelopment. (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe incidence of vocal cord paralysis (VCP), secondary to injury to the left recurrent laryngeal nerve by the clip or ligature ranges between 1 and 64%. Infants with VCP were more likely to develop BPD, to need prolonged mechanical ventilation and have been known to receive a slightly increased incidence of gastrostomy tube insertion. (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eNeurodevelopmental outcomes reported in premature infants with a hsPDA have been mixed. Some studies exhibited similar long-term outcomes in infants with a PDA regardless of the type of treatment (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) while other studies have shown worse NDI at 2\u0026ndash;3 years of age in infants receiving either medical or surgical treatment. (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) Many investigators have correlated surgical ligation with negative neurodevelopmental outcome. Mechanisms which may be associated with NDI may include surgical effects, anesthesia effects or postoperative hemodynamic compromise affecting cerebral perfusion. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) One study done in Sweden found that primary surgical ligation of a PDA was associated with increased risk for NDI at 6.5 years of age. (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) Another study in Canada found that surgical ligation of the PDA was associated with decreased mortality but increased NDI in early childhood. (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eELBW infants are the most vulnerable to the morbidities of surgical ligation. Complications associated with surgical ligation have led to the consideration of other strategies for ductal closure among preterm infants. Percutaneous Transcatheter Closure (PTC) of the PDA is now a viable option in the ELBW population and is one of the safest cardiac interventional procedures. (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) Studies have demonstrated successful and safe transcatheter PDA closure. (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) In recent years, devices suitable to close the PDA for premature infants\u0026thinsp;\u0026ge;\u0026thinsp;700g at the time of procedure have become available. (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eIt remains to be seen whether PTC represents a paradigm shift in PDA management that will result in improved short- and long-term outcomes, including less BPD, NEC/Spontaneous intestinal perforation, IVH or improved neurodevelopment. (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe aim of this study is to examine the short- and long-term effects of PTC vs surgical closure. Our hypothesis is that PTC is associated with fewer short-term morbidities and has better neurodevelopmental outcomes compared to surgical ligation in infants born less than 29 weeks gestation.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTrial Design\u003c/h2\u003e \u003cp\u003eThis was an IRB approved single center observational retrospective-prospective case control study of premature infants born between 23\u0026ndash;29 weeks gestation between the years 2015\u0026ndash;2021 who underwent surgical ligation or PTC of the PDA. Variables were compared between the intervention groups, as well as with matched controls. Matched controls were infants in the same gestational age (GA) range with a PDA at the time of screening that didn\u0026rsquo;t receive medical or surgical treatment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy Population\u003c/h2\u003e \u003cp\u003eInfants born between 23\u0026ndash;29 weeks gestation who had an echocardiographically confirmed large PDA deemed to be hemodynamically significant requiring closure by the treating physician were eligible. Participants were further stratified into those who received surgical ligation or PTC. These patients were then followed at 2 to 3 years corrected gestational age (CGA) at the high risk Regional Neonatal Follow up Program associated with the NICU at Maria Fareri Children\u0026rsquo;s Hospital (MFCH) at Westchester Medical Center, Valhalla, NY, U.S. for neurodevelopmental (ND) evaluation. Exclusion criteria included infants with a hsPDA requiring only medical treatment, congenital heart disease, weight of less than 700g at time of PDA closure or chromosomal abnormalities.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cp\u003eStandard practice for ELBW infants admitted to the MFCH NICU includes a screening echocardiogram performed on day of life (DOL) 3 to 5 to evaluate for the presence of a hsPDA. If a hsPDA is detected, Ibuprofen or Indomethacin will be prescribed. If 2 or more courses of COX inhibitors fail, and a hsPDA persists at the time of the repeat echocardiography, it is instrumentally closed. Prior to 2019, this was only achievable via surgical ligation. In 2019, PTC was introduced at this center and was an option for closure of a hsPDA for those infants 700g and above at the neonatologists\u0026rsquo; discretion.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eData was collected from the patient's electronic medical records, entered into and analyzed using SPSS version 26 (IBM Corp, Armonk, NY, USA). Categorical variables were compared utilizing a Chi-square test; continuous variables were compared utilizing t-test or Mann-Whitney U test when appropriate. Statistical significance is considered to be a p value\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Results were presented as mean (SD) or n (%) as appropriate. This study was approved by the IRB of New York Medical College and WMC.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003ePatient demographics and maternal characteristics\u003c/h2\u003e \u003cp\u003eVariables included maternal age, education level and race, multiple pregnancy, history of intrauterine growth restriction (IUGR), hypertension during pregnancy, preterm labor, preterm premature rupture of the membranes (PPROM, defined as membrane rupture before 37 weeks of gestation (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)), delivery via C-section, maternal chorioamnionitis, and antenatal use of steroids, antibiotics and magnesium. Infant characteristics included GA at birth, gender, birth weight (BW), out born status and DOL at transfer.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eOutcome variables\u003c/h2\u003e \u003cp\u003eOutcomes assessed included history of NEC stage IIa and above (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), severe IVH defined as Papille Grade III or Grade IV IVH (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e), retinopathy of prematurity (ROP) stage I and above (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), PLS defined by the need for hemodynamic support in the first 24 hours post ligation or transcatheter closure (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e), VCP diagnosed by the lack of vocal cord movement on direct bronchoscopy or laryngoscopy, bronchopulmonary dysplasia defined as the requirement for supplemental oxygen or need positive pressure ventilation at 36 weeks postmenstrual age (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), transfer to chronic care facility, anthropometrics on discharge (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e) and death.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eNeurodevelopmental outcomes\u003c/h2\u003e \u003cp\u003eNeurodevelopmental outcomes assessed between two and three years corrected age were determined by the Bayley Scales of Infant Development 3rd ed (BSID III). Composite scores for cognition, language, and motor function were recorded. Mean composite scores for each is 100 with a 15 point standard deviation (SD). Composite scores were further categorized to be normal (score of \u0026ge;\u0026thinsp;85), mild impairment (70\u0026ndash;84), moderate impairment (55\u0026ndash;69) and severe impairment (\u0026lt;\u0026thinsp;55).\u003c/p\u003e \u003cp\u003eFurther receipt of early intervention services at the time of Bayley testing was reported.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003ePatient demographics and maternal characteristics\u003c/h2\u003e \u003cp\u003eA total of 48 infant charts were evaluated, 17 in the surgical ligation group, 16 in the PTC group (intervention groups), and 15 controls (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). We observed that infants in the control group were delivered to younger mothers (28\u0026plusmn;3.5 (controls) vs. 34\u0026plusmn;6.4 (surgical ligation) and 31\u0026plusmn;6 years (PTC), p\u0026thinsp;=\u0026thinsp;0.01) compared to the intervention groups. Infants in the surgical ligation group were more likely to be born to mothers with a diagnosis of PPROM (52.9% (surgical ligation) vs. 26.7% (controls) and 12.5% (PTC), p\u0026thinsp;=\u0026thinsp;0.04). All mothers received at least 1 dose of antenatal steroids. Infants in the control and surgical ligation groups were more likely to be delivered to mothers who received a full course of antenatal steroids (66.7% (controls) and 58.8% (surgical ligation) vs. 13.3% (PTC), p\u0026thinsp;=\u0026thinsp;0.01).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cem\u003ePatient demographics and maternal characteristics\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eSurgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003eControls vs. Surgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eControls\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;15\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaternal age years, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34 (\u0026plusmn;6.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31 (\u0026plusmn;6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28 (\u0026plusmn;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e34 (\u0026plusmn;6.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e31 (\u0026plusmn;6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eMaternal race, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHispanic\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e0.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6 (40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"4\" rowspan=\"5\"\u003e \u003cp\u003e0.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCaucasian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIndian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAfrican-American\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMultiple pregnancy, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIUGR, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4 (25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaternal Hypertension, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePreterm labor, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (76.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (87.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13 (86.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (76.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14 (87.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.64\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePPROM, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (26.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.04\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eC-section, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (64.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (73.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9 (60%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (64.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e11 (73.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.74\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChorioamnionitis, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (29.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (29.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntibiotics, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (71.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMagnesium, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (73.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11 (91.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e11 (73.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFull course of antenatal steroids, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (58.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.008\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e10 (58.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePerinatal characteristics\u003c/h2\u003e \u003cp\u003eThere was a significant difference in GA and BW. Infants in the control group were born at a later GA (26.5 \u0026plusmn;1.7 (controls) vs. 24.8\u0026plusmn;1.6 (surgical ligation) and 25.2\u0026plusmn;1.6 (PTC), p\u0026thinsp;=\u0026thinsp;0.02) and higher BW (1029\u0026plusmn;228.8 (controls) vs. 727.6\u0026plusmn;222.6 (surgical ligation) and 731.88\u0026plusmn;200 (PTC), p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) compared to the intervention groups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). When surgical and PTC groups were compared, there was no statistical difference in GA or BW.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cem\u003ePerinatal characteristics\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eSurgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003eControls vs. Surgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eControls\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;15\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGestational age, week, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.8 (\u0026plusmn;1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.2 (\u0026plusmn;\u0026thinsp;1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e26.5 (\u0026plusmn;1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e24.8 (\u0026plusmn;1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e25.2 (1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale gender, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (76.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11 (73.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (76.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBirth weight, g, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e727.6 (\u0026plusmn;222.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e731.88 (\u0026plusmn;200)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1029 (\u0026plusmn;228.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e727.6 (\u0026plusmn;222.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e731.88 (\u0026plusmn;200)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutborn, n, (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (37.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6 (37.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDOL at transfer, day, mean (SD)\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (\u0026plusmn;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.8 (\u0026plusmn;20.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6.7 (\u0026plusmn;11.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (\u0026plusmn;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e21.8 (\u0026plusmn;20.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAny surfactant, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 (88.22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (93.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15 (88.22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCulture proven infection ever\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNEC stage IIa and above ever\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.91\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere IVH ever\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e0.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003e\u003csup\u003e1\u003c/sup\u003eBased on total out born infants\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThere were 3 (17.6%) out born infants in the surgical group, and 6 (37.5%) in the PTC group. There was no difference in out born status between groups, however there was a trend for the transcatheter closure patients to be more likely out born, and to be transferred at a later DOL.\u003c/p\u003e \u003cp\u003eInfants in the surgical and PTC groups were more likely to have developed any culture proven infection, compared to the controls (6.7% (controls) vs. 41.2% (surgical ligation) and 56.3% (PTC), p\u0026thinsp;=\u0026thinsp;0.01). However, most of these culture proven infections occurred prior to the procedure (35.3% (surgical) and 43.8% (PTC), p\u0026thinsp;=\u0026thinsp;0.62), as opposed to after the procedure (23.5% (surgical) and 18.8% (PTC), p\u0026thinsp;=\u0026thinsp;0.74).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eMorbidities before intervention among intervention groups\u003c/h2\u003e \u003cp\u003eWhen comparing only those infants in the two procedural intervention groups, the PTC group had an older CGA (29\u0026plusmn;3 vs. 33\u0026plusmn;5.2, p\u0026thinsp;=\u0026thinsp;0.01), greater weight (1053\u0026plusmn;405.5 vs. 1615\u0026plusmn;926.7, p\u0026thinsp;=\u0026thinsp;0.03) and later DOL (30\u0026plusmn;18.5 vs. 54\u0026plusmn;34.4, p\u0026thinsp;=\u0026thinsp;0.02) at the time of the procedure (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Infants in the surgical group had a higher creatinine prior to their procedure (0.71\u0026plusmn;0.31, 0.48\u0026plusmn;0.15, p\u0026thinsp;=\u0026thinsp;0.01). There was no difference in type of ventilatory support used before the procedure between groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cem\u003eMorbidities before and after intervention\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMorbidities before intervention\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCGA\u003csup\u003e1\u003c/sup\u003e at intervention, week, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29 (\u0026plusmn;3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33 (\u0026plusmn;5.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight\u003csup\u003e1\u003c/sup\u003e at intervention, g, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1053 (\u0026plusmn;405.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1615 (\u0026plusmn;926.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.03\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDOL\u003csup\u003e1\u003c/sup\u003e at intervention, day, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30 (\u0026plusmn;18.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e54 (\u0026plusmn;34.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCulture proven infection, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (35.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.62\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eMedical treatment for PDA, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e0.75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1 course\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (47.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (37.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2 courses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (47.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNEC stage IIa and above, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.26\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere IVH, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eMechanical ventilation, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon-invasive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (25%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.61\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInvasive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (82.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eType of invasive ventilator\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConventional\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (35.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (58.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHigh frequency\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (41.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHct before procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34.2 (\u0026plusmn;4.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.4 (\u0026plusmn;3.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHct after procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34.4 (\u0026plusmn;4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33.8 (\u0026plusmn;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.63\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCr before procedure, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.71 (\u0026plusmn;0.31)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.48 (\u0026plusmn;0.15)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCr after procedure, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.73 (\u0026plusmn;0.41)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.46 (\u0026plusmn;0.14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCr difference before and after procedure, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.02 (\u0026plusmn;0.17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-0.01 (\u0026plusmn;0.07)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.54\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMorbidities after intervention\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eType of invasive ventilator, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConventional\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (35.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.055\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHigh frequency\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (64.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDays on mechanical ventilation, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18.6 (\u0026plusmn;29.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.7 (\u0026plusmn;42.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAchieved RA before discharge, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (58.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.88\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePOD achievement of RA, day, mean (SD) \u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79.3 (\u0026plusmn;23.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45.9 (\u0026plusmn;26.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.014\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDOL achievement of RA, day, mean (SD) \u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e106.2 (\u0026plusmn;24.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e85.1 (\u0026plusmn;35.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCGA achievement of RA, week, mean (SD) \u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40.1 (\u0026plusmn;3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38.5 (\u0026plusmn;2.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.24\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVasopressors, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCulture proven infection, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (23.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.74\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNEC stage IIa and above, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.16\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePOD initiation of enteral feeds, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.5 (\u0026plusmn;5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.4 (\u0026plusmn;1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePOD achievement of full enteral feeds, day, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.7 (\u0026plusmn;7.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.1 (\u0026plusmn;8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAchieved full oral feeds before discharge, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (76.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13 (81.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.74\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePOD achievement of full oral feeds, day, mean (SD)\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e76 (\u0026plusmn;32.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61 (\u0026plusmn;26.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDOL achievement of full oral feeds, day, mean (SD) \u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e99.3 (\u0026plusmn;42.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e113.8 (\u0026plusmn;34.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCGA achievement of full oral feeds, week, mean (SD) \u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40.5 (\u0026plusmn;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41.7 (\u0026plusmn;4.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003csup\u003e1\u003c/sup\u003eAt intervention\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003csup\u003e2\u003c/sup\u003eBased on 26 infants on invasive mechanical ventilation\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003csup\u003e3\u003c/sup\u003eBased on infants who achieved RA status before discharge\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003e\u003csup\u003e4\u003c/sup\u003eBased on infants who achieved full oral feeds before discharge\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics post intervention among intervention groups\u003c/h2\u003e \u003cp\u003eInfants in the surgical group were more likely to require treatment with a high frequency ventilator post procedure, although this trend did not reach significance (64.7% v. 31.3%, p\u0026thinsp;=\u0026thinsp;0.055) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Creatinine level after intervention was higher in the surgical ligation group (0.73\u0026plusmn;0.41 vs. 0.46\u0026plusmn;0.14, p\u0026thinsp;=\u0026thinsp;0.02), however, there was no difference in change in creatinine level before and after the procedure (0.02\u0026plusmn;0.17 vs. -0.01\u0026plusmn;0.07, p\u0026thinsp;=\u0026thinsp;0.54) between interventional groups.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cem\u003eMorbidities on discharge\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eSurgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003eControls vs. Surgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eControls\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;15\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eROP, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eROP requiring treatment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.89\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere IVH*, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.84\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVocal cord paralysis, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (41.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.03\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBPD, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (94.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (93.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (26.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e16 (94.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e15 (93.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTracheostomy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eG-tube\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eDisposition on discharge\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDischarge home\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (82.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (80%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14 (82.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12 (75%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDischarge home on oxygen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (35.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 (35.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.34\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransfer to chronic care facility\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.37\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDischarge on oxygen\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransfer to lower level NICU\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.34\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMortality\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDOL at discharge, day (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e138.5 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e133.1 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e77.8 (\u0026plusmn;27.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e138.5 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e133.1 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCGA at discharge, week (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44.8 (\u0026plusmn;5.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e44.3 (\u0026plusmn;5.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e37.8 (\u0026plusmn;3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e44.8 (\u0026plusmn;5.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e44.3 (\u0026plusmn;5.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLOS, day (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e138.5 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e126.6 (\u0026plusmn;44.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e76.9 (\u0026plusmn;30.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e138.5 (\u0026plusmn;41.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e126.6 (\u0026plusmn;44.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.01\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight percentile (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28.3 (\u0026plusmn;23.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.1 (\u0026plusmn;17.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42.3 (\u0026plusmn;23.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e28.3 (\u0026plusmn;23.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e22.1 (\u0026plusmn;17.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.04\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHead circumference percentile (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36.2 (\u0026plusmn;28.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.4 (\u0026plusmn;23.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e54.3 (\u0026plusmn;31.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e36.2 (\u0026plusmn;28.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e35.4 (\u0026plusmn;23.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eInfants in the PTC group initiated enteral feeds post procedure earlier compared to the surgical group (POD 1.4\u0026plusmn;1 vs. 4.5\u0026plusmn;5, p\u0026thinsp;=\u0026thinsp;0.02). Infants in the PTC group reached full enteral feeds sooner on POD 7, whereas infants in the surgical group did so on POD 10, though not reaching statistical significance.\u003c/p\u003e \u003cp\u003e Some patients in each intervention group were not able to reach full oral feeds or RA prior to discharge which occurred at similar rates between intervention groups. Of those who achieved RA before discharge, infants in the PTC group did so at an earlier post procedure day compared to the surgical group (POD 79.3\u0026plusmn;23.1 (surgical ligation) vs. 45.9\u0026plusmn;6.6 (PTC), p\u0026thinsp;\u0026lt;\u0026thinsp;0.01). Infants in the PTC group reached RA status at an earlier DOL (85.1\u0026plusmn;35.5 (PTC) vs. 106.2\u0026plusmn;24.6 (surgical ligation), p\u0026thinsp;=\u0026thinsp;0.11) and CGA (38.5\u0026plusmn;2.5 (PTC) vs. 40.1\u0026plusmn;3.1 (surgical ligation), p\u0026thinsp;=\u0026thinsp;0.24). This was a difference by 2 to 3 weeks, not reaching, statistical significance however clinically is impactful and was accomplished despite procedural intervention occurring at a later CGA and DOL in the PTC group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eMorbidities at discharge intervention and control groups\u003c/h2\u003e \u003cp\u003eInfants in the surgical and PTC groups were more likely to have developed ROP and BPD, compared to controls (6.7% (controls) vs 70.6% (surgical ligation) and 75% (PTC), p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). When comparing the intervention groups to one another, there was no difference in rates of ROP or BPD. Surgical ligation was more likely to be associated with VCP. (41.7% vs. 12.5%, p\u0026thinsp;=\u0026thinsp;0.03). On further analysis, we found that infants with VCP reached RA status at a later POD (88\u0026plusmn;22.8 vs. 55.6\u0026plusmn;29, p\u0026thinsp;=\u0026thinsp;0.038), compared to infants without VCP.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cem\u003eNeurodevelopmental outcomes\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eSurgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003eControls vs. Surgical vs. PTC\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;12\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eControls\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;15\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSurgical\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;16\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePTC\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;12\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003ep\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eNDI according to Bayley cognitive composite score, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNormal\u0026thinsp;\u0026gt;\u0026thinsp;85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (80%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMild 70\u0026ndash;84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate 55\u0026ndash;69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere\u0026thinsp;\u0026lt;\u0026thinsp;54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eNDI according to Bayley language composite score, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNormal\u0026thinsp;\u0026gt;\u0026thinsp;85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (58.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.55\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9 (60%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e7 (58.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.85\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMild 70\u0026ndash;84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (13.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (8.3%%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate 55\u0026ndash;69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere\u0026thinsp;\u0026lt;\u0026thinsp;54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e \u003cp\u003eNDI according to Bayley motor composite score, n (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNormal\u0026thinsp;\u0026gt;\u0026thinsp;85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13 (86.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMild 70\u0026ndash;84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate 55\u0026ndash;69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (6.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere\u0026thinsp;\u0026lt;\u0026thinsp;54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEarly intervention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (87.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (83.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8 (53.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14 (87.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10 (83.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePhysical therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOccupational therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpeech therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (81.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (81.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8 (53.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (81.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e9 (81.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.15\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecial educator\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (45.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (68.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5 (45.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e\u003cb\u003e0.02\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eInfants in the intervention groups were discharged at a later DOL (77.8\u0026plusmn;27.6 (controls) vs. 138.5\u0026plusmn;41.8 (surgical ligation) and 133.1\u0026plusmn;41.8 (PTC), p\u0026thinsp;\u0026lt;\u0026thinsp;0.01), CGA (37.8\u0026plusmn;3.5 (controls) vs. 44.8\u0026plusmn;5.1 (surgical ligation) and 44.3\u0026plusmn;5.4 (PTC), p\u0026thinsp;\u0026lt;\u0026thinsp;0.01), and had a longer LOS compared to the control group. No difference was seen when comparing these variables between the two intervention groups.\u003c/p\u003e \u003cp\u003eInfants in the control group were discharged at a greater weight percentile compared to either of the two intervention groups (42.3\u0026plusmn;23.6 (controls) vs. 28.3\u0026plusmn;23.3 (surgical ligation) and 22.1\u0026plusmn;17.4 (PTC), p\u0026thinsp;=\u0026thinsp;0.04), while no difference was seen between the two intervention groups (28.3\u0026plusmn;23.3 vs. 22.1\u0026plusmn;17.4, p\u0026thinsp;=\u0026thinsp;0.4). (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eNeurodevelopmental outcomes\u003c/h2\u003e \u003cp\u003e Of the 48 infants included in the study, 42 were followed at The Regional Neonatal Follow Up Program affiliated with Maria Fareri Children\u0026rsquo;s Hospital. All controls were followed. One patient in the surgical group moved out of the country. Two patients in the PTC group moved out of state, 1 was unable to be reached and 1 died before discharge due to complications from BPD. Overall, 89.4% of the patients were followed. CGA at assessment was between 22 to 30 months in all the study population, which was not significant both when comparing intervention groups with controls (p\u0026thinsp;=\u0026thinsp;0.213) and when comparing only intervention groups (p\u0026thinsp;=\u0026thinsp;0.34). There was no difference in NDI between groups. Both intervention groups were more likely to have a special educator, compared to controls.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study represents a novel contribution to the literature providing insight into short-term morbidities, outcomes at discharge, and long-term neurodevelopmental outcomes among a cohort of premature infants treated for a hsPDA who underwent surgical ligation or PTC, compared with infants with a PDA for which no intervention occurred. Our primary objective was to evaluate whether PTC in the 23-29-week age group had better short-term outcomes and better neurodevelopmental outcomes than their surgical counterparts.\u003c/p\u003e \u003cp\u003eTherapeutic options for a hsPDA include supportive treatment, pharmacological therapy, and surgical ligation, all of which have their advantages, limitations and consequences. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) Researchers have found that infants with a medically and/or surgically treated hsPDA had more comorbidities at discharge compared to infants treated conservatively. Speculation remains however that this correlation is predicated upon the medical or surgical group being sicker at baseline. (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) Furthermore, the burning question persists: Is it truly worth the repercussions to eliminate a hsPDA at an earlier age in this particularly fragile patient group?\u003c/p\u003e \u003cp\u003eWe chose the most vulnerable group of patients to study, infants between 23\u0026ndash;29 weeks, because they are the group who have the most morbidities. Previous studies show the association between GA, BW and the occurrence of PDA. A meta-analysis performed by Liu et al demonstrated that a lower GA and lower BW are associated with the development of a hsPDA. (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) In our study, infants in the intervention groups who developed a hsPDA necessitating medical and/or surgical treatment were born at a younger GA and smaller BW, compared to the control group. These infants are therefore inherently at increased risk for morbidities associated with prematurity.\u003c/p\u003e \u003cp\u003eLooking at our study group of ELBW infants, infants in both intervention groups had similar gestational age and weight at birth. Patients in the PTC group were older and larger at the time of the procedure compared to the surgical ligation group. This may be related to the fact that nearly 38% of patients who received PTC were out born.\u003c/p\u003e \u003cp\u003eWe found that those in the surgically ligated group had higher creatinine levels both before and after the intervention as compared to the PTC group. Lenoir et al. did a similar study and found that creatinine levels before procedure were also higher in the surgical group. (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) Other studies have not found this type of an association of hsPDA with AKI (acute kidney injury). (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e) Low birth weight and early GA have been associated with AKI related to the decreased number of nephrons and GFR in these patients. (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) The fact that the surgical group in our cohort was of smaller size and more premature at the time of intervention compared to the PTC group may explain the above findings. Elevated creatinine levels demonstrated in the surgical ligation group may be more a function of a paucity of nephrons and arrest of kidney development in a younger and smaller population rather than due to the prolonged effects of a hsPDA. The procedural intervention itself, whether surgical or PTC, did not affect the change in creatinine level between the two groups.\u003c/p\u003e \u003cp\u003eWe found that the PTC group reached RA status 2 to 3 weeks earlier than the surgical group post procedure, which is likely secondary to being older at the time of procedure. Further, infants in the surgical group, who were also younger and smaller at the time of procedure, were more likely to require high frequency ventilation after their procedure. Neither of these conditions reached statistical significance, however, these negative effects on respiratory outcomes can be considered clinically significant. These findings are similar to others who have also noted this improved time to wean respiratory support in the transcatheter group. (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e) These findings may be reflective of the need to deflate the lung for the procedure, and then re-inflate the lung after the procedure with the associated inflammatory effects (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e).\u003c/p\u003e \u003cp\u003ePatients in the surgical group also took longer to initiate enteral feeds post procedure. Previous research has studied the benefits of earlier initiation of enteral feeds after a surgical intervention, which may include improved weight gain, shorter duration of parenteral nutrition, decreased feeding intolerance and decreased length of stay. (\u003cspan additionalcitationids=\"CR36\" citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe presence of a hsPDA has been long associated with higher rates of BPD, IVH, NEC and ROP.(\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e) The rates of these significant NICU morbidities were higher in both intervention groups compared to the control group, however, when comparing the two intervention groups to one another, there was no difference. Likewise, there were no distinctions in terms of DOL, CGA at discharge, or length of stay (LOS) between the two intervention groups. These findings suggest that the early implementation of surgical intervention at a lower weight and earlier gestational age for hsPDA management, aimed at enhancing clinical outcomes, does not result in a substantial reduction in these targeted NICU morbidities.\u003c/p\u003e \u003cp\u003eVocal cord paralysis has long been associated with surgical ligation of the PDA. Benjamin et al. did a retrospective study to determine the relationship between left vocal cord paralysis (LVCP) and respiratory morbidities, feeding and growth difficulties and neurodevelopmental impairment at 18 to 22-month follow-up. (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e) They found a 40% rate of LVCP in their population, which was similar to the 41.7% rate of LVCP in the surgical ligation group found in this study. This didn\u0026rsquo;t result in a higher need for tracheostomy or g-tube between the two intervention groups. However, we did see that infants with VCP, most of whom were in the surgical group, reached RA status at later POD. It could be speculated that the presence of VCP as a consequence of surgical ligation of the PDA could impact the infants need for respiratory support.\u003c/p\u003e \u003cp\u003ePrevious research has hinted at a link between extended hsPDA exposure and adverse outcomes, such as BPD and deteriorating NDI. (\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e) We found no difference in NDI between groups. Infants within the PTC group experienced a longer hsPDA exposure, owing to their later gestational age at the time of intervention. Despite this prolonged exposure, our data did not point to an elevated risk of concurrent comorbidities. This finding supports the notion that early interventional closure of a hsPDA may not lead to a reduction in associated comorbidities.\u003c/p\u003e \u003cp\u003eIn conclusion, considering the morbidities associated with surgical ligation, our findings strongly advocate for PTC as an alternative for PDA closure in ELBW premature infants. Despite the fact that infants in the PTC group had an older DOL and CGA, and a higher weight at the time of procedure, there was no increased incidence of severe morbidities such as severe IVH, ROP, BPD, NEC, sepsis, prolonged LOS or worse NDI as a result of prolonged exposure to a hsPDA. The evidence suggests that delaying the intervention until infants reach the appropriate size criteria for transcatheter closure could potentially lead to a reduction in short-term comorbidities and a quicker recovery period after the procedure without increasing the risk for acute NICU morbidities or future NDI.\u003c/p\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eLimitations:\u003c/h2\u003e \u003cp\u003eWe acknowledge that our sample size was small. As more procedures are done, we will have the opportunity to investigate further the specific details which influence infant outcomes. This was also a retrospective prospective study, thus, the population studied was not randomized. As a result, differing management styles of the neonatologists over time may introduce a bias and a difficulty in designating a control group\u003c/p\u003e \u003cp\u003eAnesthesia exposure has been associated with worse NDI in the preterm population. (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e) This information could not be retrieved from the medical records for the current study, hence impact of anesthesia exposure in this population could not be assessed.\u003c/p\u003e \u003cp\u003eA total of 1 patient in the surgical group, and 3 in the PTC group were lost to follow up. However, a follow up rate 89.4% was achieved. Although our findings did not reveal a difference in NDI between the groups, it is imperative to acknowledge the limitations of our smaller sample size, which may have obscured potentially meaningful associations.\u003c/p\u003e \u003cp\u003eFinally, part of our population was evaluated during the COVID-19 pandemic. A proportion of our population was receiving some type of therapy through the Early Intervention program at the time of Bayley evaluation. It is well known that during the COVID-19 pandemic, many healthcare facilities and therapy centers were forced to limit in-person services due to safety concerns and lockdown measures. (\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e, \u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e) This disruption could have potential implications for access to speech, occupational, and physical therapy services for former preterm infants, and may have impacted their neurodevelopment.\u003c/p\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003eAcknowledgements: We thank Westchester Medical Center and the High Risk Regional Neonatal Follow up Program associated with the NICU at Maria Fareri Children\u0026rsquo;s Hospital (MFCH) at Westchester Medical Center who allowed us to collect data for our study.\u003c/p\u003e\n\u003cp\u003eConflicts of interest\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003eAuthor contributions\u003c/p\u003e\n\u003cp\u003eMCF drafted the manuscript and performed the initial analysis. JK assisted with analysis, reviewed drafts of manuscripts and made substantial contributions to draft. JG contributed to the analysis plan and reviewed drafts of manuscripts and made contributions to draft. AR conceived the original project, scientific design, analysis plan, and reviewed and made contributions to multiple drafts of the paper. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eNone declared.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSu BH, Lin HY, Chiu HY, Tsai ML, Chen YT, Lu IC. Therapeutic strategy of patent ductus arteriosus in extremely preterm infants. Vol. 61, Pediatrics and Neonatology. Elsevier (Singapore) Pte Ltd; 2020. p. 133\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eH Al Nemri AM. 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Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13052-021-00956-2\u003c/span\u003e\u003cspan address=\"10.1186/s13052-021-00956-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBenjamin JR, Smith PB, Cotten CM, Jaggers J, Goldstein RF, Malcolm WF. Long-term morbidities associated with vocal cord paralysis after surgical closure of a patent ductus arteriosus in extremely low birth weight infants. Journal of Perinatology. 2010;30(6):408\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYoun YA, Seo YM, Yum SK, Sung IK. Patent ductus arteriosus ligation on neurodevelopmental outcomes at corrected 2 years. Ital J Pediatr. 2019;45(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWalsh BH, Paul RA, Inder TE, Shimony JS, Smyser CD, Rogers CE. 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COMPARISON OF GOAL ACHIEVEMENT WHEN TRANSITIONING FROM IN-PERSON THERAPY TO TELETHERAPY IN WESTCHESTER COUNTY EARLY INTERVENTION PROGRAM DUE TO THE COVID-19 PANDEMIC. Int J Telerehabil. 2022;14(1).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-perinatology","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jp","sideBox":"Learn more about [Journal of Perinatology](http://www.nature.com/jp/)","snPcode":"41372","submissionUrl":"https://mts-jper.nature.com/cgi-bin/main.plex","title":"Journal of Perinatology","twitterHandle":"@jperinatology","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-3851197/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3851197/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eObjective: Review a cohort of preterm infants \u0026lt;29 weeks of gestation at birth and compare morbidities and neurodevelopmental outcomes based on type of PDA closure.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStudy design: Single center observational retrospective-prospective case control study of premature infants who underwent surgical ligation or percutaneous transcatheter closure of the PDA. Neurodevelopmental testing was done using the Bayley Scales of Infant Development 3rd ed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults: The percutaneous transcatheter closure group had an older corrected gestational age and weight at the time of procedure, and started enteral feeds and achieved room air status at an earlier post procedure day. Infants in the surgical ligation group were more likely to experience vocal cord paralysis. There was no difference in neurodevelopmental outcomes between groups.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusion: Waiting for infants to achieve the appropriate size for percutaneous transcatheter closure of the PDA may lead to reduced short-term complications without increasing the risk of neurodevelopmental impairment.\u003c/p\u003e","manuscriptTitle":"Morbidity and neurodevelopmental outcomes at 2 years in preterm infants undergoing percutaneous transcatheter closure vs. surgical ligation of the PDA","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-18 15:20:41","doi":"10.21203/rs.3.rs-3851197/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2024-02-07T16:21:17+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-02-07T02:33:29+00:00","index":2,"fulltext":"This content is not available."},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-01-30T20:10:35+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-01-19T07:18:41+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-01-16T16:05:30+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2024-01-16T11:17:57+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Perinatology","date":"2024-01-12T19:30:38+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-01-12T10:42:15+00:00","index":"","fulltext":""},{"type":"checksFailed","content":"","date":"2024-01-11T10:45:30+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-01-10T18:42:50+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-perinatology","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"jp","sideBox":"Learn more about [Journal of Perinatology](http://www.nature.com/jp/)","snPcode":"41372","submissionUrl":"https://mts-jper.nature.com/cgi-bin/main.plex","title":"Journal of Perinatology","twitterHandle":"@jperinatology","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"9545c5c1-0d87-4ce9-bcad-a91e4b87a935","owner":[],"postedDate":"January 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":28168060,"name":"Health sciences/Diseases/Neurological disorders/Neurodevelopmental disorders"},{"id":28168061,"name":"Health sciences/Medical research/Outcomes research"},{"id":28168062,"name":"Health sciences/Diseases/Cardiovascular diseases"}],"tags":[],"updatedAt":"2024-06-04T15:48:17+00:00","versionOfRecord":{"articleIdentity":"rs-3851197","link":"https://doi.org/10.1038/s41372-024-02019-w","journal":{"identity":"journal-of-perinatology","isVorOnly":false,"title":"Journal of Perinatology"},"publishedOn":"2024-06-03 04:00:00","publishedOnDateReadable":"June 3rd, 2024"},"versionCreatedAt":"2024-01-18 15:20:41","video":"","vorDoi":"10.1038/s41372-024-02019-w","vorDoiUrl":"https://doi.org/10.1038/s41372-024-02019-w","workflowStages":[]},"version":"v1","identity":"rs-3851197","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3851197","identity":"rs-3851197","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}