Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol

Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol | 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 Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol Zuzanna Kubicka, Eyad Zahr, Henry A Feldman, Tamara Rousseau, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4201813/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Aug, 2024 Read the published version in Journal of Perinatology → Version 1 posted 9 You are reading this latest preprint version Abstract Objectives ( 1 ) To demonstrate feasibility and safety of surfactant administration via laryngeal mask airway (LMA) as a first-line therapy. ( 2 ) To measure treatment success, defined as avoidance of intubation/invasive mechanical ventilation, and determine if specific clinical variables could predict success/failure. Study design: Observational cohort with eligible infants given surfactant using one type of LMA via standardized protocol. Data was captured prospectively followed by retrospective chart review. Results 150 infants ≥ 1250g and 28.3–41.1 weeks gestation were included. First-line LMA surfactant therapy was successful in 70% of the infants and those infants weaned to room air significantly quicker than infants requiring subsequent intubation/mechanical ventilation (p = 0.01 by 72h, p = 0.003 by 96h). Clinical variables assessed could not predict treatment success/failure. Complications were infrequent and did not differ between groups. Conclusion First-line LMA surfactant is feasible and safe for certain infants. Prediction of treatment success was not possible in our cohort. Health sciences/Medical research/Outcomes research Health sciences/Diseases/Respiratory tract diseases Figures Figure 1 Introduction Previously published data suggests that non-invasive administration of surfactant to neonates is feasible, safe and offers potential benefits such as less need for invasive mechanical ventilation and intubation, a decrease in oxygen requirement as measured by FIO 2 and an increase in non-invasive ventilation success. 1–5 To date, two main approaches to non-invasive surfactant administration have been described: placement of a thin catheter through the vocal cords after visualization with laryngoscopy (“less invasive surfactant administration” or LISA) and placement of a supraglottic airway device (SAD) without laryngoscopy followed by insertion of catheter through the laryngeal mask. The possible benefits of utilizing SAD over LISA are ease of placement and minimization of potential complications of intubation including oxygen desaturation, bradycardia, changes in blood pressure that may increase the risk of intracranial hemorrhage, and trauma to the oropharyngeal tissue. 2, 4, 6–8 In contrast, LISA requires at least the same skills as intubation and carries similar risks including transient hypoxemia and bradycardia with possible changes in cerebral perfusion rates. 6–8, 9–14 During LISA, positive pressure ventilation (PPV) can be potentially avoided whereas with SAD, PPV is still required to instill the surfactant. During both methods, infants can remain on a non-invasive ventilation (NIV) mode. 1–5 Currently available sizes of SAD devices limit the application of this procedure to birth weights > 1000g, with the smallest infant reported having a birth weight of 1050g. 2,16 Unfortunately, prior randomized controlled trials (RCTs) on surfactant delivery by SAD have been heterogeneous in entry criteria, ranges of gestational age and birth weight, different premedication protocols and used various SAD devices. 2, 16–23 In our NICU, we aimed to optimize NIV, which was already being routinely used and widely accepted by staff following the implementation of a comprehensive and standardized respiratory care bundle. 24 Therefore, we created a protocol for the routine use of LMA for surfactant administration for infants > 1250g at birth, primarily modeled on the procedure described by Roberts, et al. 2,21 This study describes our prospective observational findings, representing the largest reported cohort of infants given surfactant therapy utilizing one type of LMA with homogenous eligibility criteria for the procedure and a standardized protocol for surfactant administration. Methods Context South Shore Hospital in Massachusetts has ~ 3500 deliveries and 450 NICU admissions per year. The NICU has 30 beds and is the only Level III NICU in the state not located within an academic medical center. Infants are cared for by a staff of seven neonatologists, five neonatal nurse practitioners (NNP), eight pediatric/neonatal certified respiratory therapists (RT), and seventy bedside nurses. No physicians-in-training or NNPs-in-training participate in patient care. Protocol implementation The protocol for administration of surfactant via LMA was implemented in September 2019 after an extensive literature review and training sessions for the neonatologists, NNPs and RTs provided by the author of one of the published RCTs. 2,21 This was followed by small group training sessions for nursing staff. (see online supplemental material: “Guideline for Surfactant administration by LMA”). Intervention The surfactant administration procedure was modeled after the method described by Roberts 2, 21 with the following differences: i-gel Size 1 LMA was utilized for all applications (i-gel, Intersurgical, UK size No. 1), atropine was not administered, and a Ballard 5F Multi-Access catheter (Avanos;Alpharetta, GA) was used and advanced to the 18cm mark approximating the tip of the catheter at the distal end of the LMA in order to instill the surfactant. In addition, PPV was limited to 30 seconds after administration and non-invasive nasal positive pressure ventilation (NIPPV) was utilized for at least one hour after the procedure, targeting mean airway pressures of 10-12mmHg. (see online supplemental material: “LMA for Surfactant Administration Algorithm”) Equipment Choice of LMA device (i-gel, Intersurgical, UK size No. 1 ) was based on published evidence suggesting its superior performance. A recent study comparing the performance of seven brands of size 1 LMA devices and two brands of face mask using self-inflating bags found that detected leaks were the lowest, as well as peak inspiratory pressure and PEEP delivered, were the highest with the i-gel brand of LMA. In addition, no insertion failures were noted during use. The i-gel device does not contain an inflating-deflating port, which is hypothesized to contribute to ease of placement. 25 The interface for continuous positive airway pressure (CPAP) and NIPPV delivery was the RAM cannula (Neotech; Valencia, CA), with cannula size based on birth weight. Both CPAP and NIPPV were delivered by an Evita Infinity V500 ventilator (Draeger Medical) once the infant was admitted into the NICU. Inclusion/exclusion/failure criteria Infants with a birth weight of ≥ 1250g requiring CPAP or NIPPV with chest radiograph findings consistent with respiratory distress syndrome and who required > 0.3 FiO 2 to maintain oxygen saturations within gestational age target ranges (≤32.6 weeks 88–92%, 33-34.6 weeks 90–95%, ≥ 35 weeks 93–97%) were included in the study cohort. Exclusion criteria for administration of surfactant via LMA included ( 1 ) birth weight < 1250g; ( 2 ) requiring a second dose of surfactant; ( 3 ) age less than 30 minutes or more than 48 hours; ( 4 ) congenital cyanotic heart disease requiring prostaglandins; ( 5 ) outside-born infants requiring intubation for transport to our hospital. Infants meeting any of these criteria were intubated for surfactant administration using standard of care clinical practice. Failure of surfactant administration by LMA (treatment failure) was defined as any of the following: ( 1 ) inability to properly position LMA device; ( 2 ) no subsequent decrease in FiO 2 below the level required prior to surfactant administration; and/or ( 3 ) FiO 2 > 0.4 within 12 hours from dosing. If failure criteria were met at any point following LMA surfactant administration, infants were intubated and, if needed, a second dose of surfactant was administered via endotracheal tube 12 hours after the first dose. Study intervention All infants born between 10/2019 and 09/2023 meeting inclusion criteria were included in the study cohort. The procedure was discussed with parents of eligible infants prior to surfactant administration and verbal consent was obtained. Each infant’s demographic data (MRN, gestational age, birth weight), bradycardia and desaturation episodes during placement, occurrence of pneumothorax and subsequent failure of the procedure (i.e., need for intubation and invasive mechanical ventilation) was captured prospectively by an RT lead using a standardized “LMA/Surfactant capture tool” (online supplement). After 150 patients underwent the procedure, a detailed retrospective chart review was conducted by eight of the neonatologists and NNPs in order to verify the prospective data collection and to capture additional maternal and neonatal demographics and outcome measures. Our primary outcome was the need for intubation and mechanical invasive ventilation following LMA surfactant administration. Our secondary outcomes were hours on NIV or invasive ventilation and hours to wean to room air. Safety and feasibility measures included the need for cardiopulmonary resuscitation during the procedure, episodes of bradycardia, desaturation and/or the need for reinsertion of the LMA during the procedure, incidence of pneumothorax, pulmonary bleeding after the procedure, surfactant reflux to the oropharynx, presence of surfactant (measured in milliliters) in the stomach and the need to re-dose if at least 75% of the volume was found. Respiratory management data measures included: ( 1 ) mode of respiratory support on admission and at the time of LMA surfactant administration; ( 2 ) age in hours and FIO 2 at the time of administration; ( 3 ) age in hours and FIO 2 at the time of subsequent intubation. Morbidities included: rates of chronic lung disease, intraventricular hemorrhage, necrotizing enterocolitis and retinopathy of prematurity. In addition, length of stay in the NICU and number of infants transferred to the well newborn nursery prior to discharge was collected. Ethical considerations This study was exempted from approval by the South Shore Hospital Institutional Review Board. Statistical analysis: We compared intubated with non-intubated infants using the Fisher exact test for discrete outcomes and the Wilcoxon rank-sum test to allow for skewed distribution of continuous outcomes. We constructed a multiple logistic regression model for intubation using three predictors: CPAP or no respiratory support at admission; age ≥ 12h at surfactant administration; and FIO 2 ≥ 40% at surfactant administration. From the fitted model we constructed a receiver operating characteristic (ROC) curve and compared the area under the curve (AUC) to the null value of 0.50 using a 95% confidence interval. We used SAS software (Cary, NC) for all statistical computations and took p < 0.05 as the criterion for statistical significance. Results All parents of eligible infants verbally consented to the non-invasive administration procedure and one hundred fifty infants were included in final analysis. One-hundred-five infants (70%) never required intubation and invasive mechanical ventilation. Comparisons were made between the infants who never required intubation and the intubated group. There were no statistically significant differences between groups with respect to maternal and neonatal characteristics including sex, race, completion of prenatal steroids, mode of delivery, Apgar scores, gestational age or birth weight, or morbidities (Table 1 ). Overall median birth weight was 2525g (1200-4480g) and median gestational age was 35.2 weeks (28.3–41.1 weeks). Overall, 57% of infants were 32.1–37.0 weeks gestation and 13% were ≤32.0 weeks. Upon NICU admission, 68% of infants were managed with CPAP, 25% with NIPPV and 7% received no positive pressure. Morbidity rates were low and did not differ between groups. There were no cases of mortality prior to discharge in this cohort. We reported four cases of Grade 1 and one case of Grade 3 intraventricular hemorrhage, one case of medical necrotizing enterocolitis and no cases of retinopathy of prematurity. The outcome of chronic lung disease defined as need for supplemental oxygen at 36 weeks postmenstrual age was only reported for infants less than 33 weeks gestational age. Three cases of chronic lung disease were identified. Table 1 Demographic and clinical characteristics N (%) or Median (min − max) p* All Intubated Not intubated N 150 45 105 Sex:Female 59 (39) 14 ( 31 ) 45 (43) 0.20 Male 91 (61) 31 (69) 60 (57) Race:White 139 (93) 41 (91) 98 (93) 0.57 Black 5 ( 3 ) 1 ( 2 ) 4 ( 4 ) Other 6 ( 4 ) 3 ( 7 ) 3 ( 3 ) Hispanic 9 ( 6 ) 2 ( 5 ) 7 ( 7 ) 0.72 Outborn 13 ( 9 ) 5 ( 11 ) 8 ( 8 ) 0.53 Multiple birth 26 ( 17 ) 7 ( 16 ) 19 ( 18 ) 0.82 Small for GA 10 ( 7 ) 5 ( 11 ) 5 ( 5 ) 0.17 Steroid complete 52 (35) 14 ( 32 ) 38 (36) 0.71 Prenatal steroids 77 (52) 25 (57) 52 (50) 0.47 Chorioamnionitis 3 ( 2 ) 1 ( 2 ) 2 ( 2 ) 1 Delivery:vaginal 41 ( 27 ) 10 ( 22 ) 31 ( 30 ) 0.43 cesarian 109 (73) 35 (78) 74 (70) GA, wk 35.2 (28.3 − 41.1) 34.7 (28.3 − 39.1) 35.3 (28.9 − 41.1) 0.32 28.3 − 32 20 ( 13 ) 7 ( 16 ) 13 ( 12 ) 0.87 32.1 − 34 36 ( 24 ) 12 ( 27 ) 24 ( 23 ) 34.1 − 37 49 ( 33 ) 14 ( 31 ) 35 ( 33 ) > 37 45 ( 30 ) 12 ( 27 ) 33 ( 31 ) Birth weight, g 2525 (1200 − 4480) 2420 (1200 − 4195) 2680 (1250 − 4480) 0.14 1200 − 1500 8 ( 5 ) 3 ( 7 ) 5 ( 5 ) 0.31 1501 − 2000 33 ( 22 ) 9 ( 20 ) 24 ( 23 ) 2001 − 3000 62 (41) 23 (51) 39 (37) > 3000 47 ( 31 ) 10 ( 22 ) 37 (35) Apgar score, 1 min 8 (2 − 9) 8 (2 − 9) 8 (2 − 9) 0.34 Apgar score, 5 min 8 (1 − 9) 9 (1 − 9) 8 (6 − 9) 0.57 NICU stay, days All 18 (0 − 113) 23 (2 − 84) 16 (0 − 113) 0.20 GA, wk:28.3 − 32 50 (16 − 84) 50 (16 − 84) 49 (27 − 82) 0.81 32.1 − 34 35 (10 − 68) 33 (21 − 68) 38 (10 − 60) 0.87 34.1 − 37 14 (1 − 113) 18 (8 − 34) 14 (1 − 113) 0.29 > 37 8 (0 − 73) 9 (2 − 27) 6 (0 − 73) 0.22 Intraventricular hemorrhage 4 ( 3 ) 3 ( 7 ) 1 ( 1 ) 0.09 Meconium aspiration syndrome 5 ( 3 ) 0 (0) 5 ( 5 ) 0.32 Bronchopulmonary dysplasia† 3 ( 9 ) 2 ( 18 ) 1 ( 4 ) 0.23 Necrotizing enterocolitis, medical 1 ( 1 ) 0 (0) 1 ( 1 ) 1 Necrotizing enterocolitis, surgical 0 (0) 0 (0) 0 (0) 1 Retinopathy of prematurity 0 (0) 0 (0) 0 (0) 1 Transfer to normal nursery 14 ( 9 ) 5 ( 11 ) 9 ( 9 ) 0.76 Death prior to discharge 0 (0) 0 (0) 0 (0) 1 *Fisher exact test of equal proportions or Wilcoxon test of equal distributions. †At 36 wk; of 35 total, 11 intubated, 24 not intubated. Outcome included only for infants < 33 wk GA. There were no statistically significant differences between intubated and non-intubated infants with respect to initial respiratory management requirements (Table 2 ) including mode of ventilation upon admission (p = 0.5); mode of ventilation at the time of surfactant administration via LMA (p = 0.5); level of PEEP required at the time of surfactant administration (p = 0.43 and p = 0.14, respectively); median timing of surfactant administration (3.75 hours [1–47 hours], p = 0.15); or median FIO 2 at the time of surfactant administration (0.33 [0.21-1.0], p = 0.57). Logistic regression modeling for intubation utilizing CPAP or no respiratory support on admission, age at surfactant administration via LMA ≥ 12 hours, and FIO 2 ≥ 0.4 did not predict procedure failure. The ROC curve did not rise much above the diagonal; area under the curve was 0.6 (95% CI 0.50—0.70). Positive predictive value was approximately 0.36, a minimal improvement over random chance considering that the prevalence of intubation in the sample was 0.30 Fig. 1 illustrates the comparison of these factors between groups. Table 2 Initial Respiratory Management N (%) or Median (min − max) p* All Intubated Not intubated 150 45 105 Ventilation on admission:CPAP 102 (68) 32 (71) 70 (67) 0.50 NIPPV 38 ( 25 ) 9 ( 20 ) 29 ( 28 ) Neither 10 ( 7 ) 4 ( 9 ) 6 ( 6 ) Ventilation at LMA:CPAP 70 (47) 18 (40) 52 (50) 0.50 NIPPV 79 (53) 27 (60) 52 (50) Neither 1 ( 1 ) 0 (0) 1 ( 1 ) At LMA PEEP on CPAP, cm H 2 O:All 70 18 52 0.43 6 14 ( 20 ) 5 ( 28 ) 9 ( 17 ) 7 43 (61) 9 (50) 34 (65) 8 13 ( 19 ) 4 ( 22 ) 9 ( 17 ) At LMA PEEP on NIPPV, cm H 2 O:All 79 27 52 0.14 6 8 ( 10 ) 4 ( 15 ) 4 ( 8 ) 7 65 (82) 23 (85) 42 (81) 8 6 ( 8 ) 0 (0) 6 ( 12 ) At LMA PIP on NIPPV, cm H 2 O 24 (20 − 28) 24 (22 − 28) 24 (20 − 28) 0.58 Age at LMA, hr 3.75 (1 − 47) 3 (1 − 30) 4 (1 − 47) 0.15 FIO 2 at LMA, % 33 (21 − 100) 34 (21 − 60) 32 (21 − 100) 0.57 *Fisher exact test of equal proportions or Wilcoxon test of equal distributions. With respect to the group of infants who went on to be intubated, the median age at intubation was 15 hours (range 1.5 − 145 hours), median FiO 2 at intubation was 0.34 (range 0.21 − 1.0), median partial pressure of carbon dioxide was 65mmHg (range 33 − 86 mmHg) and 60% received a second dose of surfactant after the initial LMA dose while 22% received two additional doses. Table 3 illustrates respiratory outcome comparisons of both groups. Non-intubated infants spent more hours on CPAP and low flow nasal cannula, although differences did not reach statistical significance, while intubated infants spent significantly longer time on high frequency oscillatory ventilation and conventional invasive ventilation (p = 0.002 and p < 0.0001, respectively). Overall, infants for whom the procedure was successful weaned off of all respiratory support to RA significantly earlier than those who failed and required subsequent intubation (50% vs 27% by 72 hours respectively, [p = 0.01]; 66% vs 39% by 96 hours, respectively, [p = 0.003] ) as shown in Fig. 1. Table 3 Respiratory Outcomes N (%) or Median (min − max) p* All Intubated Not intubated 150 45 105 CPAP, hr 39 (0 − 488) 48 (0 − 333) 37 (0 − 488) 0.64 NIPPV, hr 11 (0 − 542) 6.5 (0 − 542) 12 (0 − 134) 0.92 LFNC, hr 0 (0 − 1008) 0 (0 − 674) 0 (0 − 1008) 0.67 Conventional ventilation, hr 0 (0 − 146) 21 (4.5 − 146) 0 (0 − 0) < 0.0001 HFOV, hr 0 (0 − 158) 0 (0 − 158) 0 (0 − 0) 0.002 Age weaned to room air, hr 84.5 (0 − 1469) 127.5 (1 − 1469) 72 (0 − 1356) 0.05 Weaned at 0 − 72 hr 64 (44) 12 ( 27 ) 52 (50) 0.01 Weaned at 0 − 96 hr 85 (58) 17 (39) 68 (66) 0.003 *Fisher exact test of equal proportions or Wilcoxon test of equal distributions. Table 4 provides the summary of safety events and feasibility of the procedure. The LMA was inserted on the first attempt in all but one case. There were no cases requiring cardiopulmonary resuscitation. Desaturation and bradycardia events were noted in 7% and 9%, respectively, of all administrations and all resolved with PPV via LMA. These events were significantly more frequent in the group of infants who failed treatment (desaturation 16% vs 3% p = 0.01, bradycardia 18% vs 5% p = 0.03). In one case, surfactant was immediately re-dosed due to > 75% volume aspirated from the stomach. Volumes of surfactant aspirated from the stomach were minimal except for this case. Surfactant reflux to the mouth was observed during 5% of administrations. Incidence of pneumothorax was 7% overall, 13% in the intubated group versus 4% in the non-intubated group (p = 0.07). Table 4 Safety events and feasibility of the procedure N (%) or Median (min − max) p* All Intubated Not intubated N 150 45 105 Desaturation 10 ( 7 ) 7 ( 16 ) 3 ( 3 ) 0.01 Bradycardia 14 ( 9 ) 8 ( 18 ) 6 ( 5 ) 0.03 Surfactant reflux to oropharynx 8 ( 5 ) 4 ( 9 ) 4 ( 4 ) 0.25 Surfactant in stomach, mL 0 (0 − 6.5) 0 (0 − 2) 0 (0 − 6.5) 0.28 Pneumothorax 10 ( 7 ) 6 ( 13 ) 4 ( 4 ) 0.07 Pulmonary bleed 0 (0) 0 (0) 0 (0) 1 Need for cardiopulmonary resuscitation 0 (0) 0 (0) 0 (0) 1 *Fisher exact test of equal proportions or Wilcoxon test of equal distributions. Discussion To our knowledge, this is the largest reported cohort of infants given surfactant via LMA using homogenous criteria for treatment eligibility and treatment failure, utilizing one type of SAD and employing a standardized protocol for surfactant administration. Previously published trials on surfactant delivery, the largest of which included 51 infants randomized to receive LMA surfactant, all included use of various types of SADs and had varied inclusion criteria. 2, 16–23 In addition, unlike the previous studies which only included infants from 27 to 37 weeks GA, 30% of our cohort was made up of infants > 37 weeks GA. 16–23 Our treatment success rate, defined as avoidance of subsequent intubation and invasive ventilation, was 70%, which is similar to rates reported by the four largest RCTs. 16–18, 21 However, unlike those studies which found no differences in time to wean to RA between groups, we found that infants for whom the procedure was successful weaned to RA significantly sooner than those who failed. 16–17, 21 This is a key finding, as it underscores one major potential clinical benefit of implementing a standardized procedure for surfactant administration using LMA and avoiding intubation and invasive ventilation of a large group of infants. Our study’s findings of ease of administration and absence of severe adverse events during or after the procedure are further strengthened by the avoidance of premedication use, other than sucrose, in our cohort. Having a procedure to administer surfactant safely and effectively without the need for sedative, paralytic and/or other medication administration avoids the short and long-term risks associated with the use of those substances in the NICU population. While only using sucrose, LMAs were placed on the first attempt in all but one case in our cohort, underscoring the ease of the procedure with the i-gel LMA. This was a positive finding compared to previous studies which reported unsuccessful first attempts of placing a SAD as ranging anywhere from 2.5–31%. 16,17, 23,27 Similarly, none of the infants in our cohort required emergent intubation, pausing of the procedure or experienced cardiorespiratory arrest despite not using atropine, which was administered in previous trials for the purpose of preventing bradycardia . 16–17, 21, 27 We reported similar rates of desaturation and bradycardia episodes as these trials, which in our case all resolved with brief PPV via LMA. 16,17 It is probable that the statistically higher rates of these events observed during LMA placement in the eventually intubated group of infants in our study might be explained by a greater severity of illness. With respect to those infants who eventually required intubation due to treatment failure, all but eight of 45 intubated infants received a second dose of surfactant 12 hours following the first and this was based on the treating clinician’s clinical judgement. We failed to ascertain specific pre-treatment respiratory management factors that would allow us to potentially predict the success or failure of LMA surfactant administration in a future trial. Our initial assumption that infants with lower levels of respiratory support on admission (CPAP or no support vs NIPPV) combined with later surfactant administration and higher FIO 2 requirements would predict subsequent failure did not provide a reliable prediction model. It is possible that novel diagnostic measures might be more useful, for example the emerging role of point of care ultrasound in RDS severity diagnostics. 26 Therefore, without a current reliable prediction model, we can only speculate that initial treatment failure may have been related to a need to provide a higher MAP via invasive ventilation, combined with surfactant deficiency. Future studies aimed at determining why certain infants fail LMA surfactant therapy should more thoroughly investigate ventilation requirements and settings in this particular group. Our cohort showed that LMA surfactant administration is safe. Historically, adverse events with intubation reported in the literature range from 18–65% and include esophageal intubation, mainstem intubation, oral/airway trauma, vomiting, cardiac arrest, hypotension, laryngospasm, pneumothorax, need for chest compressions, need for emergent intubation, and/or severe desaturation (defined as oxygen saturation 20% from baseline). 28– 32 Alternatively, previous reports estimated rates of pneumothorax in groups of infants receiving LMA surfactant to be 0–20%. 4, 16,17,19–22 We reported a similar rate, with only three intubated infants in our entire cohort requiring needle decompression or placement of a chest tube, which was thought to be due to disease severity rather than procedural complications. This hypothesis is supported by the fact that overall pneumothorax rates in our NICU during the study period remained at our baseline rate of 2–3%. The major limitation of our study is the observational design with no control group. As a result, whether some infants would have remained on NIV and not required intubation even without surfactant administration via LMA cannot be ascertained. In addition, some infants in our cohort received surfactant with FIO 2 lower than 0.3, deviating from the clinical protocol. Published RCTs comparing early intervention with surfactant via LMA versus maintenance on CPAP without surfactant administration, and surfactant administration via an LMA versus via intubation, surfactant administration, extubation (InSurE) are better suited to assess the outcome of need for mechanical ventilation or reduction in FIO 2 in intervention and control groups. 16–23 Finally, due to size limits of the i-gel LMA size 1, compared to other studies our cohort represents an overall healthier NICU population with larger more mature infants and very low rates of morbidity and no mortality. We believe that future directions should include the design of a smaller SAD to administer surfactant to very low birth weight infants which, in combination with NIV, could potentially decrease the risk of developing CLD in this higher risk group of infants. Conclusions In summary, we demonstrated that the administration of surfactant via LMA can be utilized easily and safely in the clinical setting as a first line therapy outside a rigorous RCT amongst infants ≥ 1250g at birth who are diagnosed with RDS and require > 0.3 FiO 2 . This method provides the additional benefits of avoiding the need for risky procedural premedication and potential complications of laryngoscopy while allowing for a faster wean off respiratory support to RA. These findings are an important addition to the currently available literature on surfactant delivery via SAD to support utilization of this approach as first line therapy in a clinical setting for a select group of newborns with RDS. Future studies should focus on determining accurate treatment success prediction models in order to further delineate which infants will benefit from LMA surfactant administration in lieu of intubation and invasive ventilation. Declarations Financial disclosure statement : The authors have no financial relationships relevant to this article to disclose. Funding source: There was no funding source for this project. Conflict of interest : Zuzanna Kubicka MD, Eyad Zahr MD, Henry A. Feldman, Tamara Rousseau MD, Theresa Welgs MD, Amy Ditzel DNP, Diana Perry MD, Molly Lacy MD, Carolyn O’Rourke RRT-NPS, Bonnie Arzuaga MD have no conflict of interest related to this study, including relevant financial interests, activities, relationships and affiliations. Author contributions : Dr Kubicka conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, collected data, drafted the initial manuscript, and reviewed and revised the manuscript. Drs Arzuaga, Welgs, Zahr, Ditzel, Perry, Rousseau and Lacy contributed to designing the study, data collection, and reviewed and revised the manuscript. Carolyn O’Rourke RRT-NPS contributed to study design, created data capture tool, contributed to data collection, and reviewed and revised the manuscript. Henry A. Feldman conceptualized and designed the study, carried out the initial and final statistical analyses, and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. Data availability: The datasets generated during and analyzed during the current study are not publicly available due to IRB restrictions but are available from the corresponding author on reasonable request. References Guthrie SO, Roberts KD. Less invasive surfactant administration methods: Who, what and how. J Perinatol. 2023 Sep 22. doi: 10.1038/s41372-023-01778-2 . Guthrie SO, Fort P, Roberts KD. Surfactant Administration Through Laryngeal or Supraglottic Airways. Neoreviews. 2021;22:e673-e688. Abdel-Latif ME, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024;1:CD008309. Roberts CT, Manley BJ, O'Shea JE, Stark M, Andersen C, et al. Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021;106:336–341. 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Kanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013;131:e502-509. Kribs A, Roll C, Göpel W, Weig C, Groneck P, et al; NINSAPP Trial Investigators. Nonintubated surfactant application vs conventional therapy in extremely preterm infants: a randomized clinical trial. JAMA Pediatr.2015;169:723–730. Dargaville PA, Aiyappan A, De Paoli AG, Kuschel CA, Kamlin COF, et al. Minimally-invasive surfactant therapy in preterm infants on continuous positive airway pressure. Arch Dis Child Fetal Neonatal Ed. 2013;98:F122–F126. Göpel W, Kribs A, Ziegler A, Laux R, Hoehn T,¨ et al; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomized, controlled trial. Lancet. 2011;378:1627–1634. Bertini G, Coviello C, Gozzini E, Bianconi T, Bresci C, et al. Change of cerebral oxygenation during surfactant treatment in preterm infants:“LISA” versus “InSurE” procedures. Neuropediatrics. 2017;48:98–103. Gallup JA, Ndakor SM, Pezzano C, Pinheiro JMB. Randomized trial of surfactant therapy via laryngeal mask airway versus brief tracheal intubation in neonates norn preterm. J Pediatr. 2023;254:17–24. Pinheiro JM, Santana-Rivas Q, Pezzano C. Randomized trial of laryngeal mask airway versus endotracheal intubation for surfactant delivery. J Perinatol. 2016;36:196–201. Barbosa RF, Simões E Silva AC, Silva YP. A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates. J Pediatr (Rio J). 2017;93:343–350. Amini E, Sheikh M, Shariat M, Dalili H, Azadi N, et al. Surfactant administration in preterm neonates using laryngeal mask airway: a randomized clinical trial. Acta Med Iran. 2019;57:348–354. Attridge JT, Stewart C, Stukenborg GJ, Kattwinkel J. Administration of rescue surfactant by laryngeal mask airway: lessons from a pilot trial. Am J Perinatol. 2013;30:201–206. Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, et al. Laryngeal mask airway for surfactant administration in neonates: a randomized, controlled trial. J Pediatr. 2018;193:40–46. Gharehbaghi M, Moghaddam YJ, Radfar R. Comparing the efficacy of surfactant administration by laryngeal mask airway and endotracheal intubation in neonatal respiratory distress syndrome. Crescent J Med Biol Sci. 2018;5:222–227. Sadeghnia A, Tanhaei M, Mohammadizadeh M, Nemati M. A comparison of surfactant administration through i-gel and ET-tube in the treatment of respiratory distress syndrome in newborns weighing more than 2000 grams. Adv Biomed Res.2014;3:160. Kubicka Z, Zahr E, Rousseau T, Feldman HA, Fiascone J. Quality improvement to reduce chronic lung disease rates in very-low birth weight infants: high compliance with a respiratory care bundle in a small NICU. J Perinatol. 2018;38:285–292. Tracy MB, Priyadarshi A, Goel D, Lowe K, Huvanandana J, et al. How do different brands of size 1 laryngeal mask airway compare with face mask ventilation in a dedicated laryngeal mask airway teaching manikin? Arch Dis Child Fetal Neonatal Ed. 2018;103:F271-F276. Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021;90:524–53 Wanous A, Brown R, Rudser K, Roberts K. Comparison of Laryngeal Mask Airway and Endotracheal Tube Placement in Neonates. J Perinatol. 2023;44:239–243. Foglia EE, Ades A, Napolitano N, Leffelman J, Nadkarni V, Nishisaki A. Factors associated with adverse events during tracheal intubation in the NICU. Neonatology. 2015;108:23–9. Hatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Whitney GM, et al. Endotracheal intubation in neonates: a prospective study of adverse safety events in 162 infants. J Pediatr. 2016;168:62–6. Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, et al. Neonatal intubation practice and outcomes: an international registry study. Pediatrics.2019;143:e20180902. Hatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Maynord PO, et al. Interventions to improve patient safety during intubation in the neonatal intensive care unit. Pediatrics. 2016;138:e20160069. Roberts KD, Leone TA, Edwards WH, Rich WD, Finer NN. Premedication for nonemergent neonatal intubations: a randomized, controlled trial comparing atropine and fentanyl to atropine, fentanyl, and mivacurium. Pediatrics. 2006;118:1583–91. Additional Declarations There is NO conflict of interest to disclose. Supplementary Files OnLineSupplementalMaterialLMASurfactantalgorithm.doc Cite Share Download PDF Status: Published Journal Publication published 30 Aug, 2024 Read the published version in Journal of Perinatology → Version 1 posted Editorial decision: revise 09 May, 2024 Review # 2 received at journal 08 May, 2024 Review # 1 received at journal 23 Apr, 2024 Reviewer # 2 agreed at journal 17 Apr, 2024 Reviewer # 1 agreed at journal 14 Apr, 2024 Reviewers invited by journal 07 Apr, 2024 Submission checks completed at journal 02 Apr, 2024 First submitted to journal 01 Apr, 2024 Editor assigned by journal 01 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Kubicka","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA10lEQVRIiWNgGAWjYDACHgY2hgQgtG9vAPIMLEjQYsBzAKRFgkgtDCAtEgkgLhFa5HvOmD14UJMmby75/OqGHwUSDPzt3Ql4tTD29pgbJBzLMdw5O6fsZg/QYRJnzm7Aq4WZn8dMIrGhgrHhdk7aDR6gFgOJXPxa2KBa7Btunkm7+YcYLTy8PSAtOYkbbrAfu02ULRI8x8qBfklLntmTw3ZbxkCCh6Bf5HuStz38UZNs289+/NnNN39s5Pjbe/FrQXajAZgkVjkIsD8gRfUoGAWjYBSMIAAAqnJFejjpjTwAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0003-1396-6050","institution":"Boston Children's Hospital","correspondingAuthor":true,"prefix":"","firstName":"Zuzanna","middleName":"","lastName":"Kubicka","suffix":""},{"id":288496973,"identity":"a1979ced-3eef-44e7-95e7-87772f19fb4d","order_by":1,"name":"Eyad Zahr","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Eyad","middleName":"","lastName":"Zahr","suffix":""},{"id":288496974,"identity":"244e501b-e6f6-4595-bc48-7368b8096f43","order_by":2,"name":"Henry A Feldman","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Henry","middleName":"A","lastName":"Feldman","suffix":""},{"id":288496975,"identity":"86e2d151-d8c8-48ba-9f71-65700982bb31","order_by":3,"name":"Tamara Rousseau","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Tamara","middleName":"","lastName":"Rousseau","suffix":""},{"id":288496976,"identity":"c0334c73-5f2d-448a-a891-99c1336f0b2a","order_by":4,"name":"Theresa Welgs","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Theresa","middleName":"","lastName":"Welgs","suffix":""},{"id":288496977,"identity":"b861d45e-30bf-4c53-bb27-c975686bf973","order_by":5,"name":"Amy Ditzel","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Amy","middleName":"","lastName":"Ditzel","suffix":""},{"id":288496978,"identity":"638c98b0-5b76-47c2-a07b-a2ef78d96ec5","order_by":6,"name":"Diana Perry","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Diana","middleName":"","lastName":"Perry","suffix":""},{"id":288496979,"identity":"93f5f4e8-072c-4cce-abb6-5aa69862caee","order_by":7,"name":"Molly Lacy","email":"","orcid":"","institution":"Boston Children's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Molly","middleName":"","lastName":"Lacy","suffix":""},{"id":288496980,"identity":"5895bfd8-486a-42b5-9cc5-fffb8ce4353e","order_by":8,"name":"Carolyn O'Rourke","email":"","orcid":"","institution":"South Shore Hospital","correspondingAuthor":false,"prefix":"","firstName":"Carolyn","middleName":"","lastName":"O'Rourke","suffix":""},{"id":288496981,"identity":"d11682d8-92ef-461a-9ff7-fa959e3957d3","order_by":9,"name":"Bonnie Arzuaga","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Bonnie","middleName":"","lastName":"Arzuaga","suffix":""}],"badges":[],"createdAt":"2024-04-01 16:25:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4201813/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4201813/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41372-024-02099-8","type":"published","date":"2024-08-30T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":54450592,"identity":"8f07fcd2-ebd9-427c-b17f-2b64cb2f2752","added_by":"auto","created_at":"2024-04-10 17:44:40","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":25466,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDistribution of initial respiratory management and timing to wean to room air\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Fig14.png","url":"https://assets-eu.researchsquare.com/files/rs-4201813/v1/f802e9de71093235d7620c39.png"},{"id":63682191,"identity":"712e7e70-0943-4b7d-ab9b-5523da955919","added_by":"auto","created_at":"2024-08-31 07:06:58","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":793306,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4201813/v1/7ae4b274-afd7-440f-ac7f-fdfcf4f5fb21.pdf"},{"id":54450593,"identity":"05edc84c-edfc-4f94-b704-6992b83cbbb8","added_by":"auto","created_at":"2024-04-10 17:44:40","extension":"doc","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":79360,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cbr\u003e\u003c/p\u003e","description":"","filename":"OnLineSupplementalMaterialLMASurfactantalgorithm.doc","url":"https://assets-eu.researchsquare.com/files/rs-4201813/v1/f38f869ea52443d296dce9b7.doc"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e conflict of interest to disclose.","formattedTitle":"Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePreviously published data suggests that non-invasive administration of surfactant to neonates is feasible, safe and offers potential benefits such as less need for invasive mechanical ventilation and intubation, a decrease in oxygen requirement as measured by FIO\u003csub\u003e2\u003c/sub\u003e and an increase in non-invasive ventilation success. \u003csup\u003e1\u0026ndash;5\u003c/sup\u003e To date, two main approaches to non-invasive surfactant administration have been described: placement of a thin catheter through the vocal cords after visualization with laryngoscopy (\u0026ldquo;less invasive surfactant administration\u0026rdquo; or LISA) and placement of a supraglottic airway device (SAD) without laryngoscopy followed by insertion of catheter through the laryngeal mask.\u003c/p\u003e \u003cp\u003eThe possible benefits of utilizing SAD over LISA are ease of placement and minimization of potential complications of intubation including oxygen desaturation, bradycardia, changes in blood pressure that may increase the risk of intracranial hemorrhage, and trauma to the oropharyngeal tissue. \u003csup\u003e2, 4, 6\u0026ndash;8\u003c/sup\u003e In contrast, LISA requires at least the same skills as intubation and carries similar risks including transient hypoxemia and bradycardia with possible changes in cerebral perfusion rates. \u003csup\u003e6\u0026ndash;8, 9\u0026ndash;14\u003c/sup\u003e During LISA, positive pressure ventilation (PPV) can be potentially avoided whereas with SAD, PPV is still required to instill the surfactant. During both methods, infants can remain on a non-invasive ventilation (NIV) mode. \u003csup\u003e1\u0026ndash;5\u003c/sup\u003e Currently available sizes of SAD devices limit the application of this procedure to birth weights\u0026thinsp;\u0026gt;\u0026thinsp;1000g, with the smallest infant reported having a birth weight of 1050g.\u003csup\u003e2,16\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eUnfortunately, prior randomized controlled trials (RCTs) on surfactant delivery by SAD have been heterogeneous in entry criteria, ranges of gestational age and birth weight, different premedication protocols and used various SAD devices. \u003csup\u003e2, 16\u0026ndash;23\u003c/sup\u003e In our NICU, we aimed to optimize NIV, which was already being routinely used and widely accepted by staff following the implementation of a comprehensive and standardized respiratory care bundle.\u003csup\u003e24\u003c/sup\u003e Therefore, we created a protocol for the routine use of LMA for surfactant administration for infants\u0026thinsp;\u0026gt;\u0026thinsp;1250g at birth, primarily modeled on the procedure described by Roberts, et al. \u003csup\u003e2,21\u003c/sup\u003e This study describes our prospective observational findings, representing the largest reported cohort of infants given surfactant therapy utilizing one type of LMA with homogenous eligibility criteria for the procedure and a standardized protocol for surfactant administration.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eContext\u003c/h2\u003e \u003cp\u003eSouth Shore Hospital in Massachusetts has ~\u0026thinsp;3500 deliveries and 450 NICU admissions per year. The NICU has 30 beds and is the only Level III NICU in the state not located within an academic medical center. Infants are cared for by a staff of seven neonatologists, five neonatal nurse practitioners (NNP), eight pediatric/neonatal certified respiratory therapists (RT), and seventy bedside nurses. No physicians-in-training or NNPs-in-training participate in patient care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProtocol implementation\u003c/h2\u003e \u003cp\u003eThe protocol for administration of surfactant via LMA was implemented in September 2019 after an extensive literature review and training sessions for the neonatologists, NNPs and RTs provided by the author of one of the published RCTs.\u003csup\u003e2,21\u003c/sup\u003e This was followed by small group training sessions for nursing staff. (see online supplemental material: \u003cem\u003e\u0026ldquo;Guideline for Surfactant administration by LMA\u0026rdquo;).\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eIntervention\u003c/h2\u003e \u003cp\u003eThe surfactant administration procedure was modeled after the method described by Roberts\u003csup\u003e2, 21\u003c/sup\u003e with the following differences: i-gel Size 1 LMA was utilized for all applications (i-gel, Intersurgical, UK size No. 1), atropine was not administered, and a Ballard 5F Multi-Access catheter (Avanos;Alpharetta, GA) was used and advanced to the 18cm mark approximating the tip of the catheter at the distal end of the LMA in order to instill the surfactant. In addition, PPV was limited to 30 seconds after administration and non-invasive nasal positive pressure ventilation (NIPPV) was utilized for at least one hour after the procedure, targeting mean airway pressures of 10-12mmHg. (see online supplemental material: \u003cem\u003e\u0026ldquo;LMA for Surfactant Administration Algorithm\u0026rdquo;)\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eEquipment\u003c/h2\u003e \u003cp\u003eChoice of LMA device (i-gel, Intersurgical, UK size No. 1\u003cem\u003e)\u003c/em\u003e was based on published evidence suggesting its superior performance. A recent study comparing the performance of seven brands of size 1 LMA devices and two brands of face mask using self-inflating bags found that detected leaks were the lowest, as well as peak inspiratory pressure and PEEP delivered, were the highest with the i-gel brand of LMA. In addition, no insertion failures were noted during use. The i-gel device does not contain an inflating-deflating port, which is hypothesized to contribute to ease of placement. \u003csup\u003e25\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe interface for continuous positive airway pressure (CPAP) and NIPPV delivery was the RAM cannula (Neotech; Valencia, CA), with cannula size based on birth weight. Both CPAP and NIPPV were delivered by an Evita Infinity V500 ventilator (Draeger Medical) once the infant was admitted into the NICU.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eInclusion/exclusion/failure criteria\u003c/h2\u003e \u003cp\u003eInfants with a birth weight of \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;1250g requiring CPAP or NIPPV with chest radiograph findings consistent with respiratory distress syndrome and who required\u0026thinsp;\u0026gt;\u0026thinsp;0.3 FiO\u003csub\u003e2\u003c/sub\u003e to maintain oxygen saturations within gestational age target ranges (\u0026le;32.6 weeks 88\u0026ndash;92%, 33-34.6 weeks 90\u0026ndash;95%, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;35 weeks 93\u0026ndash;97%) were included in the study cohort.\u003c/p\u003e \u003cp\u003eExclusion criteria for administration of surfactant via LMA included (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) birth weight\u0026thinsp;\u0026lt;\u0026thinsp;1250g; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) requiring a second dose of surfactant; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) age less than 30 minutes or more than 48 hours; (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) congenital cyanotic heart disease requiring prostaglandins; (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) outside-born infants requiring intubation for transport to our hospital. Infants meeting any of these criteria were intubated for surfactant administration using standard of care clinical practice.\u003c/p\u003e \u003cp\u003eFailure of surfactant administration by LMA (treatment failure) was defined as any of the following: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) inability to properly position LMA device; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) no subsequent decrease in FiO\u003csub\u003e2\u003c/sub\u003e below the level required prior to surfactant administration; and/or (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) FiO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.4 within 12 hours from dosing. If failure criteria were met at any point following LMA surfactant administration, infants were intubated and, if needed, a second dose of surfactant was administered via endotracheal tube 12 hours after the first dose.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStudy intervention\u003c/h2\u003e \u003cp\u003eAll infants born between 10/2019 and 09/2023 meeting inclusion criteria were included in the study cohort. The procedure was discussed with parents of eligible infants prior to surfactant administration and verbal consent was obtained.\u003c/p\u003e \u003cp\u003eEach infant\u0026rsquo;s demographic data (MRN, gestational age, birth weight), bradycardia and desaturation episodes during placement, occurrence of pneumothorax and subsequent failure of the procedure (i.e., need for intubation and invasive mechanical ventilation) was captured prospectively by an RT lead using a standardized \u003cem\u003e\u0026ldquo;LMA/Surfactant capture tool\u0026rdquo;\u003c/em\u003e (online supplement). After 150 patients underwent the procedure, a detailed retrospective chart review was conducted by eight of the neonatologists and NNPs in order to verify the prospective data collection and to capture additional maternal and neonatal demographics and outcome measures.\u003c/p\u003e \u003cp\u003eOur primary outcome was the need for intubation and mechanical invasive ventilation following LMA surfactant administration. Our secondary outcomes were hours on NIV or invasive ventilation and hours to wean to room air. Safety and feasibility measures included the need for cardiopulmonary resuscitation during the procedure, episodes of bradycardia, desaturation and/or the need for reinsertion of the LMA during the procedure, incidence of pneumothorax, pulmonary bleeding after the procedure, surfactant reflux to the oropharynx, presence of surfactant (measured in milliliters) in the stomach and the need to re-dose if at least 75% of the volume was found.\u003c/p\u003e \u003cp\u003eRespiratory management data measures included: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) mode of respiratory support on admission and at the time of LMA surfactant administration; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) age in hours and FIO\u003csub\u003e2\u003c/sub\u003e at the time of administration; (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) age in hours and FIO\u003csub\u003e2\u003c/sub\u003e at the time of subsequent intubation.\u003c/p\u003e \u003cp\u003eMorbidities included: rates of chronic lung disease, intraventricular hemorrhage, necrotizing enterocolitis and retinopathy of prematurity. In addition, length of stay in the NICU and number of infants transferred to the well newborn nursery prior to discharge was collected.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eEthical considerations\u003c/h2\u003e \u003cp\u003eThis study was exempted from approval by the South Shore Hospital Institutional Review Board.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis:\u003c/h2\u003e \u003cp\u003eWe compared intubated with non-intubated infants using the Fisher exact test for discrete outcomes and the Wilcoxon rank-sum test to allow for skewed distribution of continuous outcomes. We constructed a multiple logistic regression model for intubation using three predictors: CPAP or no respiratory support at admission; age\u0026thinsp;\u0026ge;\u0026thinsp;12h at surfactant administration; and FIO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026ge;\u0026thinsp;40% at surfactant administration. From the fitted model we constructed a receiver operating characteristic (ROC) curve and compared the area under the curve (AUC) to the null value of 0.50 using a 95% confidence interval. We used SAS software (Cary, NC) for all statistical computations and took p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 as the criterion for statistical significance.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e All parents of eligible infants verbally consented to the non-invasive administration procedure and one hundred fifty infants were included in final analysis. One-hundred-five infants (70%) never required intubation and invasive mechanical ventilation. Comparisons were made between the infants who never required intubation and the intubated group.\u003c/p\u003e \u003cp\u003eThere were no statistically significant differences between groups with respect to maternal and neonatal characteristics including sex, race, completion of prenatal steroids, mode of delivery, Apgar scores, gestational age or birth weight, or morbidities (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Overall median birth weight was 2525g (1200-4480g) and median gestational age was 35.2 weeks (28.3\u0026ndash;41.1 weeks). Overall, 57% of infants were 32.1\u0026ndash;37.0 weeks gestation and 13% were \u0026le;32.0 weeks. Upon NICU admission, 68% of infants were managed with CPAP, 25% with NIPPV and 7% received no positive pressure. Morbidity rates were low and did not differ between groups. There were no cases of mortality prior to discharge in this cohort. We reported four cases of Grade 1 and one case of Grade 3 intraventricular hemorrhage, one case of medical necrotizing enterocolitis and no cases of retinopathy of prematurity. The outcome of chronic lung disease defined as need for supplemental oxygen at 36 weeks postmenstrual age was only reported for infants less than 33 weeks gestational age. Three cases of chronic lung disease were identified.\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\u003eDemographic and clinical characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eN (%) or Median (min\u0026thinsp;\u0026minus;\u0026thinsp;max)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntubated\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNot intubated\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex:Female\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e59 (39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e45 (43)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e91 (61)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31 (69)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60 (57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRace:White\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e139 (93)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41 (91)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e98 (93)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlack\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\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\u003e9 (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.72\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutborn\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.53\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMultiple birth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26 (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19 (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.82\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSmall for GA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSteroid complete\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e52 (35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38 (36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.71\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrenatal steroids\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (52)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (57)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52 (50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.47\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChorioamnionitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDelivery:vaginal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e41 (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e31 (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.43\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ecesarian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e109 (73)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35 (78)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74 (70)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGA, wk\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35.2 (28.3\u0026thinsp;\u0026minus;\u0026thinsp;41.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34.7 (28.3\u0026thinsp;\u0026minus;\u0026thinsp;39.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35.3 (28.9\u0026thinsp;\u0026minus;\u0026thinsp;41.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e28.3\u0026thinsp;\u0026minus;\u0026thinsp;32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e32.1\u0026thinsp;\u0026minus;\u0026thinsp;34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36 (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24 (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e34.1\u0026thinsp;\u0026minus;\u0026thinsp;37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e49 (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35 (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45 (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBirth weight, g\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2525 (1200\u0026thinsp;\u0026minus;\u0026thinsp;4480)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2420 (1200\u0026thinsp;\u0026minus;\u0026thinsp;4195)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2680 (1250\u0026thinsp;\u0026minus;\u0026thinsp;4480)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1200\u0026thinsp;\u0026minus;\u0026thinsp;1500\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.31\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1501\u0026thinsp;\u0026minus;\u0026thinsp;2000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24 (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2001\u0026thinsp;\u0026minus;\u0026thinsp;3000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e62 (41)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e39 (37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;3000\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37 (35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eApgar score, 1 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (2\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (2\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (2\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.34\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eApgar score, 5 min\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (1\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (1\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (6\u0026thinsp;\u0026minus;\u0026thinsp;9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNICU stay, days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAll\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 (0\u0026thinsp;\u0026minus;\u0026thinsp;113)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (2\u0026thinsp;\u0026minus;\u0026thinsp;84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16 (0\u0026thinsp;\u0026minus;\u0026thinsp;113)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.20\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGA, wk:28.3\u0026thinsp;\u0026minus;\u0026thinsp;32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50 (16\u0026thinsp;\u0026minus;\u0026thinsp;84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e50 (16\u0026thinsp;\u0026minus;\u0026thinsp;84)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49 (27\u0026thinsp;\u0026minus;\u0026thinsp;82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.81\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e32.1\u0026thinsp;\u0026minus;\u0026thinsp;34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (10\u0026thinsp;\u0026minus;\u0026thinsp;68)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33 (21\u0026thinsp;\u0026minus;\u0026thinsp;68)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38 (10\u0026thinsp;\u0026minus;\u0026thinsp;60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e34.1\u0026thinsp;\u0026minus;\u0026thinsp;37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (1\u0026thinsp;\u0026minus;\u0026thinsp;113)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (8\u0026thinsp;\u0026minus;\u0026thinsp;34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14 (1\u0026thinsp;\u0026minus;\u0026thinsp;113)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (0\u0026thinsp;\u0026minus;\u0026thinsp;73)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (2\u0026thinsp;\u0026minus;\u0026thinsp;27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (0\u0026thinsp;\u0026minus;\u0026thinsp;73)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntraventricular hemorrhage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMeconium aspiration syndrome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\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\u003e5 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBronchopulmonary dysplasia\u0026dagger;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNecrotizing enterocolitis, medical\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\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\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNecrotizing enterocolitis, surgical\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\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRetinopathy of prematurity\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\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTransfer to normal nursery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.76\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDeath prior to discharge\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\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003e*Fisher exact test of equal proportions or Wilcoxon test of equal distributions.\u003c/p\u003e \u003cp\u003e\u0026dagger;At 36 wk; of 35 total, 11 intubated, 24 not intubated. Outcome included only for infants\u0026thinsp;\u0026lt;\u0026thinsp;33 wk GA.\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\u003eThere were no statistically significant differences between intubated and non-intubated infants with respect to initial respiratory management requirements (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) including mode of ventilation upon admission (p\u0026thinsp;=\u0026thinsp;0.5); mode of ventilation at the time of surfactant administration via LMA (p\u0026thinsp;=\u0026thinsp;0.5); level of PEEP required at the time of surfactant administration (p\u0026thinsp;=\u0026thinsp;0.43 and p\u0026thinsp;=\u0026thinsp;0.14, respectively); median timing of surfactant administration (3.75 hours [1\u0026ndash;47 hours], p\u0026thinsp;=\u0026thinsp;0.15); or median FIO\u003csub\u003e2\u003c/sub\u003e at the time of surfactant administration (0.33 [0.21-1.0], p\u0026thinsp;=\u0026thinsp;0.57). Logistic regression modeling for intubation utilizing CPAP or no respiratory support on admission, age at surfactant administration via LMA\u0026thinsp;\u0026ge;\u0026thinsp;12 hours, and FIO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026ge;\u0026thinsp;0.4 did not predict procedure failure. The ROC curve did not rise much above the diagonal; area under the curve was 0.6 (95% CI 0.50\u0026mdash;0.70). Positive predictive value was approximately 0.36, a minimal improvement over random chance considering that the prevalence of intubation in the sample was 0.30 Fig.\u0026nbsp;1 illustrates the comparison of these factors between groups.\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\u003eInitial Respiratory Management\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eN (%) or Median (min\u0026thinsp;\u0026minus;\u0026thinsp;max)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntubated\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNot intubated\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVentilation on admission:CPAP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e102 (68)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32 (71)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e70 (67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNIPPV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38 (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29 (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeither\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVentilation at LMA:CPAP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e70 (47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52 (50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNIPPV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79 (53)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27 (60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52 (50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeither\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\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\u003e1 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAt LMA PEEP on CPAP, cm H\u003csub\u003e2\u003c/sub\u003eO:All\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.43\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43 (61)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e34 (65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAt LMA PEEP on NIPPV, cm H\u003csub\u003e2\u003c/sub\u003eO:All\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65 (82)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (85)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e42 (81)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)\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\u003e6 (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAt LMA PIP on NIPPV, cm H\u003csub\u003e2\u003c/sub\u003eO\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (20\u0026thinsp;\u0026minus;\u0026thinsp;28)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (22\u0026thinsp;\u0026minus;\u0026thinsp;28)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24 (20\u0026thinsp;\u0026minus;\u0026thinsp;28)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge at LMA, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.75 (1\u0026thinsp;\u0026minus;\u0026thinsp;47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (1\u0026thinsp;\u0026minus;\u0026thinsp;30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (1\u0026thinsp;\u0026minus;\u0026thinsp;47)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.15\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFIO\u003csub\u003e2\u003c/sub\u003e at LMA, %\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33 (21\u0026thinsp;\u0026minus;\u0026thinsp;100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34 (21\u0026thinsp;\u0026minus;\u0026thinsp;60)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e32 (21\u0026thinsp;\u0026minus;\u0026thinsp;100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003e*Fisher exact test of equal proportions or Wilcoxon test of equal distributions.\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\u003eWith respect to the group of infants who went on to be intubated, the median age at intubation was 15 hours (range 1.5\u0026thinsp;\u0026minus;\u0026thinsp;145 hours), median FiO\u003csub\u003e2\u003c/sub\u003e at intubation was 0.34 (range 0.21\u0026thinsp;\u0026minus;\u0026thinsp;1.0), median partial pressure of carbon dioxide was 65mmHg (range 33\u0026thinsp;\u0026minus;\u0026thinsp;86 mmHg) and 60% received a second dose of surfactant after the initial LMA dose while 22% received two additional doses.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e illustrates respiratory outcome comparisons of both groups. Non-intubated infants spent more hours on CPAP and low flow nasal cannula, although differences did not reach statistical significance, while intubated infants spent significantly longer time on high frequency oscillatory ventilation and conventional invasive ventilation (p\u0026thinsp;=\u0026thinsp;0.002 and p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, respectively). Overall, infants for whom the procedure was successful weaned off of all respiratory support to RA significantly earlier than those who failed and required subsequent intubation (50% vs 27% by 72 hours respectively, [p\u0026thinsp;=\u0026thinsp;0.01]; 66% vs 39% by 96 hours, respectively, [p\u0026thinsp;=\u0026thinsp;0.003] ) as shown in Fig.\u0026nbsp;1.\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\u003eRespiratory Outcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eN (%) or Median (min\u0026thinsp;\u0026minus;\u0026thinsp;max)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntubated\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNot intubated\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCPAP, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39 (0\u0026thinsp;\u0026minus;\u0026thinsp;488)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48 (0\u0026thinsp;\u0026minus;\u0026thinsp;333)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e37 (0\u0026thinsp;\u0026minus;\u0026thinsp;488)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.64\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNIPPV, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (0\u0026thinsp;\u0026minus;\u0026thinsp;542)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.5 (0\u0026thinsp;\u0026minus;\u0026thinsp;542)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (0\u0026thinsp;\u0026minus;\u0026thinsp;134)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.92\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLFNC, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;1008)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;674)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;1008)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConventional ventilation, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;146)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21 (4.5\u0026thinsp;\u0026minus;\u0026thinsp;146)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHFOV, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;158)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;158)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.002\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge weaned to room air, hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e84.5 (0\u0026thinsp;\u0026minus;\u0026thinsp;1469)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e127.5 (1\u0026thinsp;\u0026minus;\u0026thinsp;1469)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e72 (0\u0026thinsp;\u0026minus;\u0026thinsp;1356)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.05\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeaned at 0\u0026thinsp;\u0026minus;\u0026thinsp;72 hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64 (44)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52 (50)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeaned at 0\u0026thinsp;\u0026minus;\u0026thinsp;96 hr\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e85 (58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17 (39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e68 (66)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.003\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003e*Fisher exact test of equal proportions or Wilcoxon test of equal distributions.\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\u003eTable\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e provides the summary of safety events and feasibility of the procedure. The LMA was inserted on the first attempt in all but one case. There were no cases requiring cardiopulmonary resuscitation. Desaturation and bradycardia events were noted in 7% and 9%, respectively, of all administrations and all resolved with PPV via LMA. These events were significantly more frequent in the group of infants who failed treatment (desaturation 16% vs 3% p\u0026thinsp;=\u0026thinsp;0.01, bradycardia 18% vs 5% p\u0026thinsp;=\u0026thinsp;0.03). In one case, surfactant was immediately re-dosed due to \u0026gt;\u0026thinsp;75% volume aspirated from the stomach. Volumes of surfactant aspirated from the stomach were minimal except for this case. Surfactant reflux to the mouth was observed during 5% of administrations. Incidence of pneumothorax was 7% overall, 13% in the intubated group versus 4% in the non-intubated group (p\u0026thinsp;=\u0026thinsp;0.07).\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\u003eSafety events and feasibility of the procedure\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eN (%) or Median (min\u0026thinsp;\u0026minus;\u0026thinsp;max)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntubated\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNot intubated\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDesaturation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBradycardia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurfactant reflux to oropharynx\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSurfactant in stomach, mL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0\u0026thinsp;\u0026minus;\u0026thinsp;6.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.28\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePneumothorax\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePulmonary bleed\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\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNeed for cardiopulmonary resuscitation\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\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e \u003cp\u003e*Fisher exact test of equal proportions or Wilcoxon test of equal distributions.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo our knowledge, this is the largest reported cohort of infants given surfactant via LMA using homogenous criteria for treatment eligibility and treatment failure, utilizing one type of SAD and employing a standardized protocol for surfactant administration. Previously published trials on surfactant delivery, the largest of which included 51 infants randomized to receive LMA surfactant, all included use of various types of SADs and had varied inclusion criteria.\u003csup\u003e2, 16\u0026ndash;23\u003c/sup\u003e In addition, unlike the previous studies which only included infants from 27 to 37 weeks GA, 30% of our cohort was made up of infants\u0026thinsp;\u0026gt;\u0026thinsp;37 weeks GA.\u003csup\u003e16\u0026ndash;23\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eOur treatment success rate, defined as avoidance of subsequent intubation and invasive ventilation, was 70%, which is similar to rates reported by the four largest RCTs.\u003csup\u003e16\u0026ndash;18, 21\u003c/sup\u003e However, unlike those studies which found no differences in time to wean to RA between groups, we found that infants for whom the procedure was successful weaned to RA significantly sooner than those who failed.\u003csup\u003e16\u0026ndash;17, 21\u003c/sup\u003e This is a key finding, as it underscores one major potential clinical benefit of implementing a standardized procedure for surfactant administration using LMA and avoiding intubation and invasive ventilation of a large group of infants.\u003c/p\u003e \u003cp\u003eOur study\u0026rsquo;s findings of ease of administration and absence of severe adverse events during or after the procedure are further strengthened by the avoidance of premedication use, other than sucrose, in our cohort. Having a procedure to administer surfactant safely and effectively without the need for sedative, paralytic and/or other medication administration avoids the short and long-term risks associated with the use of those substances in the NICU population. While only using sucrose, LMAs were placed on the first attempt in all but one case in our cohort, underscoring the ease of the procedure with the i-gel LMA. This was a positive finding compared to previous studies which reported unsuccessful first attempts of placing a SAD as ranging anywhere from 2.5\u0026ndash;31%. \u003csup\u003e16,17, 23,27\u003c/sup\u003e Similarly, none of the infants in our cohort required emergent intubation, pausing of the procedure or experienced cardiorespiratory arrest despite not using atropine, which was administered in previous trials for the purpose of preventing bradycardia .\u003csup\u003e16\u0026ndash;17, 21, 27\u003c/sup\u003e We reported similar rates of desaturation and bradycardia episodes as these trials, which in our case all resolved with brief PPV via LMA.\u003csup\u003e16,17\u003c/sup\u003e It is probable that the statistically higher rates of these events observed during LMA placement in the eventually intubated group of infants in our study might be explained by a greater severity of illness.\u003c/p\u003e \u003cp\u003eWith respect to those infants who eventually required intubation due to treatment failure, all but eight of 45 intubated infants received a second dose of surfactant 12 hours following the first and this was based on the treating clinician\u0026rsquo;s clinical judgement. We failed to ascertain specific pre-treatment respiratory management factors that would allow us to potentially predict the success or failure of LMA surfactant administration in a future trial. Our initial assumption that infants with lower levels of respiratory support on admission (CPAP or no support vs NIPPV) combined with later surfactant administration and higher FIO\u003csub\u003e2\u003c/sub\u003e requirements would predict subsequent failure did not provide a reliable prediction model. It is possible that novel diagnostic measures might be more useful, for example the emerging role of point of care ultrasound in RDS severity diagnostics.\u003csup\u003e26\u003c/sup\u003e Therefore, without a current reliable prediction model, we can only speculate that initial treatment failure may have been related to a need to provide a higher MAP via invasive ventilation, combined with surfactant deficiency. Future studies aimed at determining why certain infants fail LMA surfactant therapy should more thoroughly investigate ventilation requirements and settings in this particular group.\u003c/p\u003e \u003cp\u003eOur cohort showed that LMA surfactant administration is safe. Historically, adverse events with intubation reported in the literature range from 18\u0026ndash;65% and include esophageal intubation, mainstem intubation, oral/airway trauma, vomiting, cardiac arrest, hypotension, laryngospasm, pneumothorax, need for chest compressions, need for emergent intubation, and/or severe desaturation (defined as oxygen saturation\u0026thinsp;\u0026lt;\u0026thinsp;60% or a decrease\u0026thinsp;\u0026gt;\u0026thinsp;20% from baseline).\u003csup\u003e28\u0026ndash; 32\u003c/sup\u003e Alternatively, previous reports estimated rates of pneumothorax in groups of infants receiving LMA surfactant to be 0\u0026ndash;20%.\u003csup\u003e4, 16,17,19\u0026ndash;22\u003c/sup\u003e We reported a similar rate, with only three intubated infants in our entire cohort requiring needle decompression or placement of a chest tube, which was thought to be due to disease severity rather than procedural complications. This hypothesis is supported by the fact that overall pneumothorax rates in our NICU during the study period remained at our baseline rate of 2\u0026ndash;3%.\u003c/p\u003e \u003cp\u003eThe major limitation of our study is the observational design with no control group. As a result, whether some infants would have remained on NIV and not required intubation even without surfactant administration via LMA cannot be ascertained. In addition, some infants in our cohort received surfactant with FIO\u003csub\u003e2\u003c/sub\u003e lower than 0.3, deviating from the clinical protocol. Published RCTs comparing early intervention with surfactant via LMA versus maintenance on CPAP without surfactant administration, and surfactant administration via an LMA versus\u003c/p\u003e \u003cp\u003evia intubation, surfactant administration, extubation (InSurE) are better suited to assess the outcome of need for mechanical ventilation or reduction in FIO\u003csub\u003e2\u003c/sub\u003e in intervention and control groups. \u003csup\u003e16\u0026ndash;23\u003c/sup\u003e Finally, due to size limits of the i-gel LMA size 1, compared to other studies our cohort represents an overall healthier NICU population with larger more mature infants and very low rates of morbidity and no mortality. We believe that future directions should include the design of a smaller SAD to administer surfactant to very low birth weight infants which, in combination with NIV, could potentially decrease the risk of developing CLD in this higher risk group of infants.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn summary, we demonstrated that the administration of surfactant via LMA can be utilized easily and safely in the clinical setting as a first line therapy outside a rigorous RCT amongst infants\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;1250g at birth who are diagnosed with RDS and require\u0026thinsp;\u0026gt;\u0026thinsp;0.3 FiO\u003csub\u003e2\u003c/sub\u003e. This method provides the additional benefits of avoiding the need for risky procedural premedication and potential complications of laryngoscopy while allowing for a faster wean off respiratory support to RA. These findings are an important addition to the currently available literature on surfactant delivery via SAD to support utilization of this approach as first line therapy in a clinical setting for a select group of newborns with RDS. Future studies should focus on determining accurate treatment success prediction models in order to further delineate which infants will benefit from LMA surfactant administration in lieu of intubation and invasive ventilation.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFinancial disclosure statement\u003c/strong\u003e:\u0026nbsp;The authors have no financial relationships relevant to this article to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding source:\u003c/strong\u003e There was no funding source for this project.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e:\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eZuzanna Kubicka MD, Eyad Zahr MD, Henry A. Feldman,\u003csup\u003e\u0026nbsp;\u003c/sup\u003eTamara Rousseau MD, Theresa Welgs MD,\u003csup\u003e\u0026nbsp;\u003c/sup\u003eAmy Ditzel DNP, Diana Perry MD, Molly Lacy MD, Carolyn O\u0026rsquo;Rourke RRT-NPS, Bonnie Arzuaga MD\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ehave no conflict of interest related to this study, including relevant financial interests, activities, relationships and affiliations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e:\u0026nbsp;Dr Kubicka conceptualized and designed the study, designed the data collection instruments, coordinated and supervised data collection, collected data, drafted the initial manuscript, and reviewed and revised the manuscript.\u003cbr\u003e\u0026nbsp;Drs Arzuaga, Welgs, Zahr, Ditzel, Perry, Rousseau and Lacy contributed to designing the study, data collection, and reviewed and revised the manuscript.\u003c/p\u003e\n\u003cp\u003eCarolyn O\u0026rsquo;Rourke RRT-NPS contributed to study design, created data capture tool, contributed to data collection,\u0026nbsp;and reviewed and revised the manuscript.\u003cbr\u003e\u0026nbsp;Henry A. Feldman conceptualized and designed the study, carried out the initial and final statistical analyses, and critically reviewed the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability:\u003c/strong\u003e The datasets generated during and analyzed during the current study are not publicly available due to IRB restrictions but are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGuthrie SO, Roberts KD. Less invasive surfactant administration methods: Who, what and how. J Perinatol. 2023 Sep 22. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1038/s41372-023-01778-2\u003c/span\u003e\u003cspan address=\"10.1038/s41372-023-01778-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuthrie SO, Fort P, Roberts KD. Surfactant Administration Through Laryngeal or Supraglottic Airways. Neoreviews. 2021;22:e673-e688.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbdel-Latif ME, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024;1:CD008309.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoberts CT, Manley BJ, O'Shea JE, Stark M, Andersen C, et al. Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021;106:336\u0026ndash;341.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCalevo MG, Veronese N, Cavallin F, Paola C, Micaglio M, et al. Supraglottic airway devices for surfactant treatment: systematic review and meta-analysis. J Perinatol. 2019;39:173\u0026ndash;183.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSingh R, Mohan CVR, Taxak S. Controlled Trial to evaluate the use of LMA for neonatal resuscitation. J Anaesthesiol Clin Pharmacol 2005;21:303\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTrevisanuto D, Cavallin F, Nguyen LN, Nguyen TV, Tran LD, et al. Supreme laryngeal mask airway versus face mask during neonatal resuscitation: A Randomized Controlled Trial. J Pediatr 2015;167:286\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhu X-Y, Lin B-C, Zhang Q-S, Ye H-M, Yu R-J, et al. A prospective evaluation of the efficacy of the laryngeal mask airway during neonatal resuscitation. Resuscitation 2011;82:1405\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eadministration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed 2017;102:F17\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKanmaz HG, Erdeve O, Canpolat FE, Mutlu B, Dilmen U. Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial. Pediatrics. 2013;131:e502-509.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKribs A, Roll C, G\u0026ouml;pel W, Weig C, Groneck P, et al; NINSAPP Trial Investigators. Nonintubated surfactant application vs conventional therapy in extremely preterm infants: a randomized clinical trial. JAMA Pediatr.2015;169:723\u0026ndash;730.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDargaville PA, Aiyappan A, De Paoli AG, Kuschel CA, Kamlin COF, et al. Minimally-invasive surfactant therapy in preterm infants on continuous positive airway pressure. Arch Dis Child Fetal Neonatal Ed. 2013;98:F122\u0026ndash;F126.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eG\u0026ouml;pel W, Kribs A, Ziegler A, Laux R, Hoehn T,\u0026uml; et al; German Neonatal Network. Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomized, controlled trial. Lancet. 2011;378:1627\u0026ndash;1634.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBertini G, Coviello C, Gozzini E, Bianconi T, Bresci C, et al. Change of cerebral oxygenation during surfactant treatment in preterm infants:\u0026ldquo;LISA\u0026rdquo; versus \u0026ldquo;InSurE\u0026rdquo; procedures. Neuropediatrics. 2017;48:98\u0026ndash;103.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGallup JA, Ndakor SM, Pezzano C, Pinheiro JMB. Randomized trial of surfactant therapy via laryngeal mask airway versus brief tracheal intubation in neonates norn preterm. J Pediatr. 2023;254:17\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePinheiro JM, Santana-Rivas Q, Pezzano C. Randomized trial of laryngeal mask airway versus endotracheal intubation for surfactant delivery. J Perinatol. 2016;36:196\u0026ndash;201.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarbosa RF, Sim\u0026otilde;es E Silva AC, Silva YP. A randomized controlled trial of the laryngeal mask airway for surfactant administration in neonates. J Pediatr (Rio J). 2017;93:343\u0026ndash;350.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmini E, Sheikh M, Shariat M, Dalili H, Azadi N, et al. Surfactant administration in preterm neonates using laryngeal mask airway: a randomized clinical trial. Acta Med Iran. 2019;57:348\u0026ndash;354.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAttridge JT, Stewart C, Stukenborg GJ, Kattwinkel J. Administration of rescue surfactant by laryngeal mask airway: lessons from a pilot trial. Am J Perinatol. 2013;30:201\u0026ndash;206.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, et al. Laryngeal mask airway for surfactant administration in neonates: a randomized, controlled trial. J Pediatr. 2018;193:40\u0026ndash;46.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGharehbaghi M, Moghaddam YJ, Radfar R. Comparing the efficacy of surfactant administration by laryngeal mask airway and endotracheal intubation in neonatal respiratory distress syndrome. Crescent J Med Biol Sci. 2018;5:222\u0026ndash;227.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSadeghnia A, Tanhaei M, Mohammadizadeh M, Nemati M. A comparison of surfactant administration through i-gel and ET-tube in the treatment of respiratory distress syndrome in newborns weighing more than 2000 grams. Adv Biomed Res.2014;3:160.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKubicka Z, Zahr E, Rousseau T, Feldman HA, Fiascone J. Quality improvement to reduce chronic lung disease rates in very-low birth weight infants: high compliance with a respiratory care bundle in a small NICU. J Perinatol. 2018;38:285\u0026ndash;292.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTracy MB, Priyadarshi A, Goel D, Lowe K, Huvanandana J, et al. How do different brands of size 1 laryngeal mask airway compare with face mask ventilation in a dedicated laryngeal mask airway teaching manikin? Arch Dis Child Fetal Neonatal Ed. 2018;103:F271-F276.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRaimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021;90:524\u0026ndash;53\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWanous A, Brown R, Rudser K, Roberts K. Comparison of Laryngeal Mask Airway and Endotracheal Tube Placement in Neonates. J Perinatol. 2023;44:239\u0026ndash;243.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFoglia EE, Ades A, Napolitano N, Leffelman J, Nadkarni V, Nishisaki A. Factors associated with adverse events during tracheal intubation in the NICU. Neonatology. 2015;108:23\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Whitney GM, et al. Endotracheal intubation in neonates: a prospective study of adverse safety events in 162 infants. J Pediatr. 2016;168:62\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFoglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, et al. Neonatal intubation practice and outcomes: an international registry study. Pediatrics.2019;143:e20180902.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHatch LD, Grubb PH, Lea AS, Walsh WF, Markham MH, Maynord PO, et al. Interventions to improve patient safety during intubation in the neonatal intensive care unit. Pediatrics. 2016;138:e20160069.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRoberts KD, Leone TA, Edwards WH, Rich WD, Finer NN. Premedication for\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003enonemergent neonatal intubations: a randomized, controlled trial comparing atropine and fentanyl to atropine, fentanyl, and mivacurium. Pediatrics. 2006;118:1583\u0026ndash;91.\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-4201813/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4201813/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) To demonstrate feasibility and safety of surfactant administration via laryngeal mask airway (LMA) as a first-line therapy. (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) To measure treatment success, defined as avoidance of intubation/invasive mechanical ventilation, and determine if specific clinical variables could predict success/failure.\u003c/p\u003e\u003ch2\u003eStudy design:\u003c/h2\u003e \u003cp\u003eObservational cohort with eligible infants given surfactant using one type of LMA via standardized protocol. Data was captured prospectively followed by retrospective chart review.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003e150 infants\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026ge;\u003c/span\u003e\u0026thinsp;1250g and 28.3\u0026ndash;41.1 weeks gestation were included. First-line LMA surfactant therapy was successful in 70% of the infants and those infants weaned to room air significantly quicker than infants requiring subsequent intubation/mechanical ventilation (p\u0026thinsp;=\u0026thinsp;0.01 by 72h, p\u0026thinsp;=\u0026thinsp;0.003 by 96h). Clinical variables assessed could not predict treatment success/failure. Complications were infrequent and did not differ between groups.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eFirst-line LMA surfactant is feasible and safe for certain infants. Prediction of treatment success was not possible in our cohort.\u003c/p\u003e","manuscriptTitle":"Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-10 17:44:36","doi":"10.21203/rs.3.rs-4201813/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"revise","date":"2024-05-09T14:57:44+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-05-08T13:56:33+00:00","index":2,"fulltext":"This content is not available."},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-04-24T00:34:40+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-04-17T12:48:26+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-04-14T19:18:09+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2024-04-07T17:12:33+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-02T09:41:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Perinatology","date":"2024-04-01T16:21:47+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-01T16:21:47+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":"4636c2a3-ba2d-42c0-a093-48e6d074c154","owner":[],"postedDate":"April 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":30372786,"name":"Health sciences/Medical research/Outcomes research"},{"id":30372787,"name":"Health sciences/Diseases/Respiratory tract diseases"}],"tags":[],"updatedAt":"2024-08-31T07:06:50+00:00","versionOfRecord":{"articleIdentity":"rs-4201813","link":"https://doi.org/10.1038/s41372-024-02099-8","journal":{"identity":"journal-of-perinatology","isVorOnly":false,"title":"Journal of Perinatology"},"publishedOn":"2024-08-30 04:00:00","publishedOnDateReadable":"August 30th, 2024"},"versionCreatedAt":"2024-04-10 17:44:36","video":"","vorDoi":"10.1038/s41372-024-02099-8","vorDoiUrl":"https://doi.org/10.1038/s41372-024-02099-8","workflowStages":[]},"version":"v1","identity":"rs-4201813","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4201813","identity":"rs-4201813","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}