Role of pulse oximetry for early detection of critical congenital heart disease among the neonates at hospitals affiliated with shiraz university of medical sciences: A pilot study.

preprint OA: closed
Full text JSON View at publisher
Full text 80,059 characters · extracted from preprint-html · click to expand
Role of pulse oximetry for early detection of critical congenital heart disease among the neonates at hospitals affiliated with shiraz university of medical sciences: A pilot study. | 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 Research Article Role of pulse oximetry for early detection of critical congenital heart disease among the neonates at hospitals affiliated with shiraz university of medical sciences: A pilot study. Reza Bahrami, Mitra Rooinpeykar, Amir Naghshzan, Ali Moradi, Mohammad Bahrami, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4565593/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background and Objective: Congenital heart disease (CHD) is a structural anomaly of the heart that manifests before birth, and it is one of the most prevalent congenital disabilities. The presentations of CHD are heterogeneous and depend on the defect type and age of the neonate. The physical examination and pulse oximetry provide a high level of accuracy, exhibiting a sensitivity of 92% and a specificity of 98% when used together. Some studies showed that pulse oximetry has an influential role in the screening of CHD. However, there are controversial cutoff levels of oxygen saturation as a Reliable screening. This study aims to evaluate the acceptable cutoff of oxygen saturation based on previous guidelines as the primary goal and the prediction of challenges in the screening program of neonates based on the Newborn Health Program. Method This prospective cohort study from September 2021 to June 2022 on 372 neonates with full inclusion criteria and follow-up. The study focused on newborns admitted to the Neonatal Intensive Care Unit (NICU) at Zainabiyeh Hospital, the tertiary referral NICU center south of Iran. The screening was conducted by qualified medical practitioners using pulse oximetry after the first day of admission. Readings above 95.5% were considered negative, while those below 90% were deemed positive. The results were 90% − 95.5%; re-evaluate after one hour. In the re-evaluation, if the result was above 95.5%, it was considered negative; if it was below 95.5%, it was considered positive. Echocardiography was conducted within 48 hours for all infants with a positive pulse oximetry result. A bedside echocardiogram was performed before discharge for all neonates. Finally, the echocardiography and pulse oximetry results were compared to evaluate the negative and positive predictive value of pulse oximetry results and cutoff. Results Among 372 neonates, 222 (59%) had a normal echocardiogram, and 150 (41%) had an abnormal echocardiogram. Among neonates with abnormal echocardiography, 96% had acyanotic disease, and more than 50% of babies whose oxygen saturation was less than 95.5% had abnormal echocardiography. Pulse oximetry with a cutoff of 95.5% had 100% sensitivity and a specificity of 84–87.5% for the diagnosis of CHD. More than 69% of babies with saturation less than 95.5% in all four limbs had an abnormal echocardiogram. Conclusion Pulse oximetry, as the screening tool, can help early detection of neonates with CHD and is also the cost-benefit method in areas lacking tertiary centers for neonatal echocardiography. Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction The incidence of CHD in various studies varies between approximately five and fifty cases per 1000 births based on screening, diagnostic programs, and genetic variations ( 1 ). CHD can be associated with other underlying genetic syndromes, such as DiGeorge syndrome, Down syndrome, and Holt-Oram syndrome ( 2 ). The prenatal prediction rate of CHD ranges from 30–60%, even in highly developed countries ( 3 ). CHD may be asymptomatic until adulthood in certain people, although typical symptoms include failure to thrive, cardiac murmur, cyanosis, dyspnea, diaphoresis, and edema ( 4 ). Given that a significant percentage of patients with CHD do not show symptoms initially and prenatal diagnosis fails to identify many cases, it is imperative to conduct early screening of newborns for CHD. Early detection can lead to improved outcomes ( 5 – 7 ). A diminished oxygen level may indicate the presence of a congenital cardiac condition ( 8 ). Pulse oximetry is an effective, non-invasive, and cost-effective diagnostic and screening technology with a sensor capable of detecting low oxygen saturation levels in the bloodstream. This is why pulse oximetry is frequently used to assess infants in neonatal intensive care units and emergency rooms and as an additional tool for evaluating babies in the delivery room, and it aids in early detection of CHD. Multiple studies have demonstrated that pulse oximetry can identify as much as 90% of critical congenital heart disorders ( 7 , 9 , 10 ). A meta-analysis study by Mahle WT has shown that pulse oximetry has a sensitivity of 69% and a specificity of 99.9% based on the results of 10 studies on 123865 patients ( 11 ). This study aims to investigate pulse oximetry's effectiveness in detecting CHDs in newborns. We will determine the sensitivity and specificity of pulse oximetry for detecting CHDs by examining readings from all four extremities. Additionally, we will consider factors such as gender, Apgar score, pregnancy age, type of delivery, birth weight, and other potential risk factors. The study was conducted at Zainabiyeh Hospital, affiliated with Shiraz University of Medical Science (SUMS), and focused on newborns admitted to the neonatal intensive care unit (NICU). Methods This study is a prospective cohort study to assess the sensitivity and specificity of pulse oximetry with arterial oxygen saturation (Sp02) in detecting CHD among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Zainabiyeh Hospital, affiliated with Shiraz University of Medical Science (SUMS), from September 2021 to June 2022. This research has been approved by Shiraz University of Medical Science's research ethics committees (Approval ID: IR.SUMS.MED.REC.1400.453), ensuring compliance with ethical standards. In this study, screening with pulse oximetry was performed 24 hours after the birth or as late as possible if an early discharge was planned. The Radical 7 pulse oximetry device by Masimo Company, located in California, USA, can show various results, such as oxygen saturation (%SpO2), pulse rate (bpm), respiration rate, total hemoglobin (SpHb g/dL), hemoglobin saturation (%SpMet), and carboxyhemoglobin saturation (%SpCO). Trained nurse educated to perform pulse oximetry on all four extremities. Environmental confounding factors were controlled before pulse oximetry. The neonate was at a suitable temperature and away from the phototherapy light. During pulse oximetry, the baby was completely calm, and it was avoided to perform pulse oximetry when the baby was crying. The probe is connected to the baby for at least 30 seconds to obtain reliable results until the device observes the appropriate curve shown in Fig. 1 . Oxygen saturation levels of pulse oximetry (SpO2) for screening were categorized as negative if saturation was above 95.5%, Positive if saturation was below 90%, and Intermediate (90-95.5%), suggesting a repeat pulse oximetry after one hour as it is showed in Fig. 2 . All infants underwent echocardiography to ensure we didn’t miss any cases. The echocardiography was done for infants with the order of Infants with positive screening results underwent echocardiography within 48 hours. A bedside echocardiogram was performed at discharge for those with negative screening but later exhibited saturation below 95.5%. Finally, echocardiography was conducted for negative screening infants before discharge. Zainabiyeh Hospital, where this study is conducted, has gynecology and neonatal departments affiliated with SUMS and serves as a center for Shiraz and surrounding cities in Fars Province. Before the implementation of pulse oximetry, parents were required to give informed consent, which ensured transparency and respected the participants' autonomy. The data were gathered through collaboration with authors using a prearranged structured Microsoft Excel format and reviewed by all authors to identify and rectify potential problems. The acquired data was analyzed using the 26th version of SPSS software, which included statistical measures such as averages and standard deviations. Results This study involved a total of 372 neonates. Of the total, 222 neonates (59.8%) were male, and 150 neonates (40.2%) were female, with a mean age and weight of 34.67 weeks and 2462 grams, respectively. According to our data, 39.8% of pregnant women didn’t have any risk factors. Gestational diabetes was the predominant risk factor in pregnant women, accounting for 28.2% of cases, followed by hyperthyroidism with 13.9%. The presence of several risk factors is shown in Fig. 3 . The average oxygen saturation (SpO2) in all extremities between male and female infants didn't have a significant difference (p-value > 0.05). The correlation coefficient of SpO2 with various variables in neonates, such as gestational age, the Apgar score neonatal age, and neonatal weight, was not significant. In this study, hyperthyroidism, gestational diabetes, hypertension, and Preeclampsia in the mother were included as risk factors, and their correlation with SpO2 was discussed. Based on the data, there was only a significant correlation between the hyperthyroidism and SpO2 of the right hand. One hundred fifty neonates (41%) had abnormal echocardiography, and 222 neonates (59%) had normal echocardiography. Among the neonates with abnormal echocardiography, 145 (96%) were acyanotic, as shown in Fig. 4 . A cutoff point of 95.5% SpO2 for all extremities has 100% sensitivity, and specificity varies between 84% and 87.5% for diagnosing CHDs. Other cutoffs were also examined, but the sensitivity and specificity decreased, so 95.5% was chosen as the best possible cutoff point. Table 1 shows the data analysis of all limbs with a 95.5% cutoff in a receiver operating characteristic (ROC) curve. Table 1 Data analysis of ROC curve in various extremities. ROC: Receiver Operating Characteristic, AUC: Area under the curve, CI: Confidence Interval. Extremity AUC 95% CI Cutoff Point Sensitivity Specificity Right Hand 0.922 0.875–0.968 95.5 100% 87.3% Right Foot 0.947 0.910–0.983 95.5 100% 87.5% Left Hand 0.927 0.878–0.977 95.5 100% 87% Left Foot 0.892 0.830–0.954 95.5 100% 84% In Figs. 5 and 6 , you can find the ROC curve for sensitivity and specificity in all four extremities. Table 2 The relationship between SPO2 in different extremities and echocardiography. Extremity SpO2 Cutoff Value Echocardiography Normal n. (%) Abnormal n. (%) Right Hand 95.5%> 88 (49.2) 91 (50.8) 95.5% 74 (46.5) 85 (53.5) 95.5% 63 (44.7) 78 (55.3) 95.5% 63 (42) 87 (58) 95.5%< 143 (64.4) 79 (35.6) One hundred seventy-nine neonates (48.1%) had right-hand SpO2 below 95.5%. Among them, 91 neonates (50.8%) had abnormal echocardiographs. In Table 2 , the results of echocardiography and SpO2 of different limbs have been shown. In the study, 52 neonates (14%) had SpO2 below the 95.5% in all four extremities, and 55 neonates (14.8%) had SpO2 below the 95.5% in three of the extremities. Table 3 shows the number of extremities with SpO2 below 95.5% and their relationship with echocardiography. Table 3 The relationship between the number of extremities with the SpO2 below 95.5% and echocardiography result. Number of extremities with SPO2 below 95.5% Echocardiography Normal Number (%) Abnormal Number (%) Total Number 0 69 (69.7) 30 (30.3) 99 1 35 (46.6) 40 (53.7) 75 2 38 (41.7) 53 (58.3) 91 3 27 (49) 28 (51) 55 4 16 (30.8) 36 (69.2) 52 The relationship between various risk factors and oxygen saturation is complex, and the only significant correlation was between hyperthyroidism and right-hand oxygen saturation. 14% of neonates had below-the-cutoff oxygen saturation in all four extremities, 69.2% of them had abnormal echocardiography too, and 14.8% of all neonates had below-the-cutoff oxygen saturation in three extremities, of which 51% had abnormal echocardiography, as you can see in Table 2 . The echocardiography results were compared with oxygen saturation in different limbs, and 48.1% of neonates had right-handed oxygen saturation below 95.5%, and among them, 50.8% had abnormal echocardiography. Discussion CHD stands as a prominent cause of mortality in neonates. Studies indicate an incidence rate of two cases of CHD per 1000 live births ( 12 ). Out of 35218 neonates, 1% had CHD, and among them, 24% were diagnosed before discharge ( 13 ). Numerous research works highlight the crucial role of pulse oximetry in CHD identification. Screening with pulse oximetry has emerged as a valuable, non-invasive, and cost-effective strategy ( 14 – 16 ). Our study is structured on integrating pulse oximetry and echocardiography to enrich the understanding of pulse oximetry's efficacy in CHD detection. Oxygen saturation was measured in the right hand (pre-ductal) and foot (post-ductal). Post-ductal measurement of SpO2 is crucial because defects involving right-to-left shunting of desaturated blood through the ductus arteriosus may go undetected with only preductal measurement. In a study on 11233 newborns with exclusion criteria for admission to the NNU unrelated to pulse oximetry. They screened 10,260 newborns with pulse oximetry, finding 23 positive results, including two with critical CHD, 16 with results from an alternative diagnosis, and 5 with normal results. The positive result was due to early screening (2 hours after birth). This study had a sensitivity of 100%, the same as ours, and a specificity of 99.8%, which was much higher than ours. However, while we followed up with echocardiography in all cases in our study, this study followed up with echocardiography only for neonates with critical CHD; this might be a reason for the high specificity of their research ( 17 ). According to a meta-analysis of ten studies, the screening sensitivity was 69.9% to diagnose critical CHD; however, it was very variable, and among those studies, some had a sensitivity of 100%, the same as our study. This study also demonstrates that a cutoff value of approximately 95% can yield the best sensitivity and specificity results, which we also used in our study ( 18 ). In another meta-analysis of 13 studies, there was no significant difference between the sensitivity of pulse oximetry in the foot alone or the foot and right hand, which is the same as the result of our study based on the ROC curve. Six of those studies conducted the screening before 24 hours, which could account for the discrepancy. One of the strengths of our study is follow-up with echocardiography, which can give a better picture of the true positive and negative. According to this meta-analysis, there was no significant difference between the sensitivity of pulse oximetry in the foot alone or the foot and right hand, which is the same as the result of our study based on the ROC curve ( 19 ). This is while, according to another study, the right foot displayed the highest specificity in pulse oximetry among extremities, the same as our study where the right foot had the highest specificity of 87.5% compared to other extremities. Variability in sensitivity and specificity levels across studies may be due to differences in the timing of measurements. Screening in the first 24 hours of life is less specific than after 24 hours of birth due to hypoxemia, commonly occurring during the transition from intrauterine to extrauterine life conditions ( 20 , 21 ). In two other studies, screening was implemented within 24 hours with a specificity of 52.4% and 44.22% ( 22 , 23 ). According to a meta-analysis of 24 cohort studies, there was a significant correlation between maternal diabetes and CHD (odds ratio: 2.65, 95% CI: 2.20–3.19). However, our study did not investigate maternal diabetes. Nonetheless, we found no significant association between gestational diabetes and CHD ( 24 ). Other studies found no statistically significant link between neonate gender, weight, delivery techniques, and the mean value of SpO2 and no connection between SpO2 levels and maternal age during pregnancy, gestational diabetes, or preeclampsia, which was reported by our study too ( 25 , 26 ). In a study on 41647 pregnant women, 215 CHDs were detected, and maternal free thyroxine (FT4) concentration was significantly associated with a higher risk of CHDs (OR:1.04, 95% CI: 1.01–1.07), which was also reported in our study ( 27 ). In this study, over 50% of newborns with SpO2 levels below 95.5% also had abnormal echocardiogram results, providing evidence for the presence of CHD. Furthermore, among newborns with SpO2 levels below 95.5%, a significant majority of 69% exhibited abnormal echocardiogram results, which shows the importance of follow-up with pulse oximetry to estimate more accurate sensitivity and specificity. Limitation Our study has particular limitations. One limitation of our study is due to the low prevalence of CHD. To establish an accurate pulse oximetry cutoff, a more extensive study population is required, and this study was conducted at a single-center hospital. However, by performing echocardiography on all neonates, we aim to have a more precise picture of the sensitivity and specificity of the specific cutoff. Another limitation of this study was the absence of following monitoring of infants who exhibited a negative SpO2 upon discharge from the hospital. This study was conducted as a preliminary investigation for a broader study population within the country to assess the significance of pulse oximetry in screening newborns for the detection of CHD. Conclusion In conclusion, pulse oximetry has proven to be a valuable and non-invasive screening tool for detecting CHD in newborns, exhibiting high sensitivity and specificity. It is crucial to do pulse oximetry within the designated period to guarantee precise outcomes. This study reveals no identifiable link between newborn variables such as gender, weight, Apgar score, and SpO2 level. Furthermore, there is no discernible correlation between pulse oximetry readings and risk factors such as gestational diabetes. The results highlight the role of pulse oximetry and stress its importance in neonatal healthcare. Declarations Ethics approval and consent to participate: This research has been approved by Shiraz University of Medical Science's research ethics committees (Approval ID: IR.SUMS.MED.REC.1400.453), ensuring compliance with ethical standards. Consent for publication: All parents agreed and gave consent to participate in the study. Availability of data and material: The datasets generated and analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: No funding. Authors' contributions Each author—B.R., R.M., N.A. (corresponding author), M.A., B.M., R.S.M., and R.M.—has made significant contributions to the conception, design, data acquisition, analysis, interpretation, software creation, drafting, or revising of the work. B.R. and N.A. significantly contributed to the design of the study and followed up on each step of the study, checking for potential bias and overseeing the data extraction by other authors. R.M. significantly worked in data collection, followed up on the data, edited different parts of the manuscript, prepared figures, and prepared tables. M.A. had a role in data collection, drafting the manuscript, study design, checking for potential errors, revising the manuscript, and preparing tables and figures. B.M., R.S.M., and R.M. contributed to data collection, study design, data analysis, drafting parts of the manuscript, checking for potential errors, and participating in table revision and editing. The submitted version has received approval from all authors, who pledge to take responsibility for their contributions and uphold the integrity of the work. Acknowledgments We would like to thank all the parents who agreed to participate in our study. References Traeger GR, Jaatinen KJ, Majesky MW, Greene CL. The Advent of Spatial Omics in Congenital Heart Disease. Current Treatment Options in Pediatrics. 2023. Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, et al. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(12):1494-563. Meller CH, Grinenco S, Aiello H, Córdoba A, Sáenz-Tejeira MM, Marantz P, et al. Congenital heart disease, prenatal diagnosis and management. Arch Argent Pediatr. 2020;118(2):e149-e61. Song L, Wang Y, Wang H, Wang G, Ma N, Meng Q, et al. Clinical profile of congenital heart diseases detected in a tertiary hospital in China: a retrospective analysis. Front Cardiovasc Med. 2023;10:1131383. Arlettaz R, Bauschatz AS, Mönkhoff M, Essers B, Bauersfeld U. The contribution of pulse oximetry to the early detection of congenital heart disease in newborns. European Journal of Pediatrics. 2006;165(2):94-8. Abu-Harb M, Wyllie J, Hey E, Richmond S, Wren C. Presentation of obstructive left heart malformations in infancy. Arch Dis Child Fetal Neonatal Ed. 1994;71(3):F179-83. Mahle WT, Martin GR, Beekman RH, 3rd, Morrow WR. Endorsement of Health and Human Services recommendation for pulse oximetry screening for critical congenital heart disease. Pediatrics. 2012;129(1):190-2. Sun R, Liu M, Lu L, Zheng Y, Zhang P. Congenital Heart Disease: Causes, Diagnosis, Symptoms, and Treatments. Cell Biochemistry and Biophysics. 2015;72(3):857-60. El Idrissi Slitine N, Bennaoui F, Sable CA, Martin GR, Hom LA, Fadel A, et al. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. International Journal of Neonatal Screening. 2020;6(3):53. Chang RK, Gurvitz M, Rodriguez S. Missed diagnosis of critical congenital heart disease. Arch Pediatr Adolesc Med. 2008;162(10):969-74. Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of Pulse Oximetry in Examining Newborns for Congenital Heart Disease. Circulation. 2009;120(5):447-58. Manzoni P, Martin GR, Sanchez Luna M, Mestrovic J, Simeoni U, Zimmermann L, et al. Pulse oximetry screening for critical congenital heart defects: a European consensus statement. The Lancet Child & Adolescent Health. 2017;1(2):88-90. Meberg A, Otterstad JE, Frøland G, Hals J, Sörland SJ. Early clinical screening of neonates for congenital heart defects: the cases we miss. Cardiol Young. 1999;9(2):169-74. Ilona CN, Nico AB, Andrew KE, Maximo V, Paolo M, Arjan BtP. Aspects of pulse oximetry screening for critical congenital heart defects: when, how and why? Archives of Disease in Childhood - Fetal and Neonatal Edition. 2016;101(2):F162. Ewer MS, Yang M, Buzdar AU. Screening for cardiac risk before anthracycline administration: What are the real benefits? Clinical Breast Cancer. 2012;12(1):1-3. Mahtab Alam MG, Gowhar Iqbal Wani, Nikhil Gupta. A study to asses pulse oximetry as a screening tool for detecting congenital heart disease. European Journal of Molecular & Clinical Medicine. 2022;9(2):1739-45. Howarth C, Jones AJ, Knowles R, Mat-Ali E, Nicholl R. The impact and efficacy of routine pulse oximetry screening for CHD in a local hospital. Cardiology in the Young. 2016;26(7):1397-405. Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009;120(5):447-58. Thangaratinam S, Brown K, Zamora J, Khan KS, Ewer AK. Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta-analysis. Lancet. 2012;379(9835):2459-64. Shenoy KD, Rao SS. Positive predictive value of pulse oximetry in the screening of critical congenital heart defects in term neonates. International Journal of Contemporary Pediatrics. 2017;4:832. Plana MN, Zamora J, Suresh G, Fernandez-Pineda L, Thangaratinam S, Ewer AK. Pulse oximetry screening for critical congenital heart defects. Cochrane Database Syst Rev. 2018;3(3):Cd011912. Mathur NB, Gupta A, Kurien S. Pulse Oximetry Screening to Detect Cyanotic Congenital Heart Disease in Sick Neonates in a Neonatal Intensive Care Unit. Indian Pediatr. 2015;52(9):769-72. Hu XJ, Zhao QM, Ma XJ, Yan WL, Ge XL, Jia B, et al. Pulse oximetry could significantly enhance the early detection of critical congenital heart disease in neonatal intensive care units. Acta Paediatr. 2016;105(11):e499-e505. Wu L, Li N, Liu Y. Association Between Maternal Factors and Risk of Congenital Heart Disease in Offspring: A Systematic Review and Meta-Analysis. Matern Child Health J. 2023;27(1):29-48. Movahedian AH, Mosayebi Z, Sagheb S. Evaluation of Pulse Oximetry in the Early Detection of Cyanotic Congenital Heart Disease in Newborns. J Tehran Heart Cent. 2016;11(2):73-8. Hamilçıkan Ş, Can E. Critical congenital heart disease screening with a pulse oximetry in neonates. J Perinat Med. 2018;46(2):203-7. Dong J, Peng T, Li MQ, Xie F, Wu JN. Association between Maternal Thyroxine and Risk of Fetal Congenital Heart Defects: A Hospital-Based Cohort Study. Int J Endocrinol. 2022;2022:3859388. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted 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. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4565593","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":324617929,"identity":"062d8e1e-86d7-40f8-97b3-7021d1f994f0","order_by":0,"name":"Reza Bahrami","email":"","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Reza","middleName":"","lastName":"Bahrami","suffix":""},{"id":324617930,"identity":"9509e169-e80e-4c2a-8587-711aec1bab57","order_by":1,"name":"Mitra Rooinpeykar","email":"","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mitra","middleName":"","lastName":"Rooinpeykar","suffix":""},{"id":324617931,"identity":"1865eb53-b507-48c8-990f-13bc4d2635f4","order_by":2,"name":"Amir Naghshzan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA90lEQVRIiWNgGAWjYBACNgbGBmYeBoYEBgkQtwKImZkb8GrhB2npgWs5A9LCiF+LJFCa+QxMC2MbSIyAFoNrh9s+n6mpzZOf3f7wc+G82mj+dqCWHxXbcGu5ndg8O+fY8WKDOweSpWduO5474zBjA2PPmdt4tTDnsB1L3CCRcECad9ux3AagFmbGNtxa7EFabP4dS5w/I7H5N++cY7nzCWkB2yLbVpPYcCOZTZq3oSZ3A3Fa+g4kbriRxmbNc+xA7kagloP4/ZL+mJnnWx3QYemPb/PU1OXOO3/44IMfFbi1QMFhVMYBQuqBoA6DMQpGwSgYBaMADgB5eWP+lhq7KwAAAABJRU5ErkJggg==","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Amir","middleName":"","lastName":"Naghshzan","suffix":""},{"id":324617932,"identity":"29226f8b-7b35-4462-a3e8-9cde8892d180","order_by":3,"name":"Ali Moradi","email":"","orcid":"","institution":"HCA Florida, Blake Hospital, University of South Florida","correspondingAuthor":false,"prefix":"","firstName":"Ali","middleName":"","lastName":"Moradi","suffix":""},{"id":324617933,"identity":"4f4c18ef-9bfa-4a0d-b221-0a9dd519c052","order_by":4,"name":"Mohammad Bahrami","email":"","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mohammad","middleName":"","lastName":"Bahrami","suffix":""},{"id":324617934,"identity":"bcac170f-5285-4db6-8f30-5c244f5c6582","order_by":5,"name":"Seyyed Mostajab Razavinejad","email":"","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Seyyed","middleName":"Mostajab","lastName":"Razavinejad","suffix":""},{"id":324617935,"identity":"69e74db1-3a53-4929-afa5-d44f16902ec9","order_by":6,"name":"Mehrdad Rezaei","email":"","orcid":"","institution":"Shiraz University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Mehrdad","middleName":"","lastName":"Rezaei","suffix":""}],"badges":[],"createdAt":"2024-06-11 16:45:39","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4565593/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4565593/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":60609637,"identity":"9d6ff706-422a-42fd-8eb0-3d093a81b3ab","added_by":"auto","created_at":"2024-07-18 18:22:08","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":88330,"visible":true,"origin":"","legend":"\u003cp\u003eThe Radical-7 Pulse C0-Oximetry with SpO2 reported after the curve showed appropriate perfusion.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/87a8ebd631ddcf6ad0a6b9bd.jpg"},{"id":60609651,"identity":"d0c831bc-0583-4b6e-bd96-3dcef9745972","added_by":"auto","created_at":"2024-07-18 18:22:10","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":76742,"visible":true,"origin":"","legend":"\u003cp\u003eScreening Method by Pulse Oximetry. RH: Right hand, F: Foot.\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/83eb27f65793625e848d75b7.jpg"},{"id":60610803,"identity":"ca90e658-0218-4e8a-9bf0-1366db37a366","added_by":"auto","created_at":"2024-07-18 18:30:08","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":45168,"visible":true,"origin":"","legend":"\u003cp\u003ePrevalence of various risk factors in the study.\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/360f22d9ba31a28efbc1124b.jpg"},{"id":60609648,"identity":"2e92a93e-dadb-4629-ad5a-6420d64cd7cf","added_by":"auto","created_at":"2024-07-18 18:22:09","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":79488,"visible":true,"origin":"","legend":"\u003cp\u003eClassification of neonates who had abnormal echocardiography.\u003c/p\u003e","description":"","filename":"4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/dbf68c8154f1a5d3dbade20b.jpg"},{"id":60609649,"identity":"604e9a99-e3fb-427f-b9a1-6343d86478c8","added_by":"auto","created_at":"2024-07-18 18:22:09","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":45134,"visible":true,"origin":"","legend":"\u003cp\u003eReceiver Operating Characteristic (ROC) curve represents pulse oximetry's sensitivity and specificity in the Right Hand.\u003c/p\u003e","description":"","filename":"5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/820d4f8ec7eddf1deabe86f5.jpg"},{"id":60610804,"identity":"117805be-6adf-40f2-95b4-cbaad6e72a75","added_by":"auto","created_at":"2024-07-18 18:30:09","extension":"jpg","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":45370,"visible":true,"origin":"","legend":"\u003cp\u003eReceiver Operating Characteristic (ROC) curve represents the Left Hand's sensitivity and specificity of pulse oximetry.\u003c/p\u003e","description":"","filename":"6.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/4c129d07ac367bef4ccab093.jpg"},{"id":62569332,"identity":"a2313b41-decb-440e-8d06-f22dbda3112e","added_by":"auto","created_at":"2024-08-16 02:52:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":820204,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4565593/v1/a7e47e19-81eb-47ef-994c-e7363c94eaeb.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Role of pulse oximetry for early detection of critical congenital heart disease among the neonates at hospitals affiliated with shiraz university of medical sciences: A pilot study.","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe incidence of CHD in various studies varies between approximately five and fifty cases per 1000 births based on screening, diagnostic programs, and genetic variations (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). CHD can be associated with other underlying genetic syndromes, such as DiGeorge syndrome, Down syndrome, and Holt-Oram syndrome (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). The prenatal prediction rate of CHD ranges from 30\u0026ndash;60%, even in highly developed countries (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). CHD may be asymptomatic until adulthood in certain people, although typical symptoms include failure to thrive, cardiac murmur, cyanosis, dyspnea, diaphoresis, and edema (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eGiven that a significant percentage of patients with CHD do not show symptoms initially and prenatal diagnosis fails to identify many cases, it is imperative to conduct early screening of newborns for CHD. Early detection can lead to improved outcomes (\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA diminished oxygen level may indicate the presence of a congenital cardiac condition (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Pulse oximetry is an effective, non-invasive, and cost-effective diagnostic and screening technology with a sensor capable of detecting low oxygen saturation levels in the bloodstream. This is why pulse oximetry is frequently used to assess infants in neonatal intensive care units and emergency rooms and as an additional tool for evaluating babies in the delivery room, and it aids in early detection of CHD. Multiple studies have demonstrated that pulse oximetry can identify as much as 90% of critical congenital heart disorders (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). A meta-analysis study by Mahle WT has shown that pulse oximetry has a sensitivity of 69% and a specificity of 99.9% based on the results of 10 studies on 123865 patients (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis study aims to investigate pulse oximetry's effectiveness in detecting CHDs in newborns. We will determine the sensitivity and specificity of pulse oximetry for detecting CHDs by examining readings from all four extremities. Additionally, we will consider factors such as gender, Apgar score, pregnancy age, type of delivery, birth weight, and other potential risk factors. The study was conducted at Zainabiyeh Hospital, affiliated with Shiraz University of Medical Science (SUMS), and focused on newborns admitted to the neonatal intensive care unit (NICU).\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis study is a prospective cohort study to assess the sensitivity and specificity of pulse oximetry with arterial oxygen saturation (Sp02) in detecting CHD among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Zainabiyeh Hospital, affiliated with Shiraz University of Medical Science (SUMS), from September 2021 to June 2022. This research has been approved by Shiraz University of Medical Science's research ethics committees (Approval ID: IR.SUMS.MED.REC.1400.453), ensuring compliance with ethical standards.\u003c/p\u003e \u003cp\u003eIn this study, screening with pulse oximetry was performed 24 hours after the birth or as late as possible if an early discharge was planned. The Radical 7 pulse oximetry device by Masimo Company, located in California, USA, can show various results, such as oxygen saturation (%SpO2), pulse rate (bpm), respiration rate, total hemoglobin (SpHb g/dL), hemoglobin saturation (%SpMet), and carboxyhemoglobin saturation (%SpCO). Trained nurse educated to perform pulse oximetry on all four extremities. Environmental confounding factors were controlled before pulse oximetry. The neonate was at a suitable temperature and away from the phototherapy light. During pulse oximetry, the baby was completely calm, and it was avoided to perform pulse oximetry when the baby was crying. The probe is connected to the baby for at least 30 seconds to obtain reliable results until the device observes the appropriate curve shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eOxygen saturation levels of pulse oximetry (SpO2) for screening were categorized as negative if saturation was above 95.5%, Positive if saturation was below 90%, and Intermediate (90-95.5%), suggesting a repeat pulse oximetry after one hour as it is showed in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll infants underwent echocardiography to ensure we didn\u0026rsquo;t miss any cases. The echocardiography was done for infants with the order of Infants with positive screening results underwent echocardiography within 48 hours. A bedside echocardiogram was performed at discharge for those with negative screening but later exhibited saturation below 95.5%. Finally, echocardiography was conducted for negative screening infants before discharge.\u003c/p\u003e \u003cp\u003eZainabiyeh Hospital, where this study is conducted, has gynecology and neonatal departments affiliated with SUMS and serves as a center for Shiraz and surrounding cities in Fars Province. Before the implementation of pulse oximetry, parents were required to give informed consent, which ensured transparency and respected the participants' autonomy.\u003c/p\u003e \u003cp\u003eThe data were gathered through collaboration with authors using a prearranged structured Microsoft Excel format and reviewed by all authors to identify and rectify potential problems. The acquired data was analyzed using the 26th version of SPSS software, which included statistical measures such as averages and standard deviations.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThis study involved a total of 372 neonates. Of the total, 222 neonates (59.8%) were male, and 150 neonates (40.2%) were female, with a mean age and weight of 34.67 weeks and 2462 grams, respectively.\u003c/p\u003e \u003cp\u003eAccording to our data, 39.8% of pregnant women didn\u0026rsquo;t have any risk factors. Gestational diabetes was the predominant risk factor in pregnant women, accounting for 28.2% of cases, followed by hyperthyroidism with 13.9%. The presence of several risk factors is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe average oxygen saturation (SpO2) in all extremities between male and female infants didn't have a significant difference (p-value\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003eThe correlation coefficient of SpO2 with various variables in neonates, such as gestational age, the Apgar score neonatal age, and neonatal weight, was not significant.\u003c/p\u003e \u003cp\u003eIn this study, hyperthyroidism, gestational diabetes, hypertension, and Preeclampsia in the mother were included as risk factors, and their correlation with SpO2 was discussed. Based on the data, there was only a significant correlation between the hyperthyroidism and SpO2 of the right hand.\u003c/p\u003e \u003cp\u003eOne hundred fifty neonates (41%) had abnormal echocardiography, and 222 neonates (59%) had normal echocardiography. Among the neonates with abnormal echocardiography, 145 (96%) were acyanotic, as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eA cutoff point of 95.5% SpO2 for all extremities has 100% sensitivity, and specificity varies between 84% and 87.5% for diagnosing CHDs. Other cutoffs were also examined, but the sensitivity and specificity decreased, so 95.5% was chosen as the best possible cutoff point. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the data analysis of all limbs with a 95.5% cutoff in a receiver operating characteristic (ROC) curve.\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\u003eData analysis of ROC curve in various extremities. ROC: Receiver Operating Characteristic, AUC: Area under the curve, CI: Confidence Interval.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExtremity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAUC\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCutoff Point\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSensitivity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSpecificity\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRight Hand\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.922\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.875\u0026ndash;0.968\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e95.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e87.3%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRight Foot\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.947\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.910\u0026ndash;0.983\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e95.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e87.5%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLeft Hand\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.927\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.878\u0026ndash;0.977\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e95.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e87%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLeft Foot\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e0.892\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.830\u0026ndash;0.954\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e95.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e84%\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\u003eIn Figs.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e and \u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e, you can find the ROC curve for sensitivity and specificity in all four extremities.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \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\u003eThe relationship between SPO2 in different extremities and echocardiography.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eExtremity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eSpO2 Cutoff Value\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eEchocardiography\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNormal n.\u003c/p\u003e \u003cp\u003e(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAbnormal n. (%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eRight Hand\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026gt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e88 (49.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e91 (50.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026lt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e115 (59.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (40.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eRight Leg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026gt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74 (46.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e85 (53.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026lt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e132 (62)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e81 (38)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eLeft Hand\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026gt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e63 (44.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (55.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026lt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e143 (61.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e88 (38.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eLeft Leg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026gt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e63 (42)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e87 (58)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.5%\u0026lt;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e143 (64.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e79 (35.6)\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\u003eOne hundred seventy-nine neonates (48.1%) had right-hand SpO2 below 95.5%. Among them, 91 neonates (50.8%) had abnormal echocardiographs. In Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the results of echocardiography and SpO2 of different limbs have been shown.\u003c/p\u003e \u003cp\u003eIn the study, 52 neonates (14%) had SpO2 below the 95.5% in all four extremities, and 55 neonates (14.8%) had SpO2 below the 95.5% in three of the extremities. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the number of extremities with SpO2 below 95.5% and their relationship with echocardiography.\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\u003eThe relationship between the number of extremities with the SpO2 below 95.5% and echocardiography result.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eNumber of extremities with SPO2 below 95.5%\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eEchocardiography\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNormal\u003c/p\u003e \u003cp\u003eNumber (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAbnormal\u003c/p\u003e \u003cp\u003eNumber (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003cp\u003eNumber\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e69 (69.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30 (30.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e99\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (46.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (53.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e75\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38 (41.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e53 (58.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e91\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27 (49)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28 (51)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (30.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36 (69.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e52\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\u003eThe relationship between various risk factors and oxygen saturation is complex, and the only significant correlation was between hyperthyroidism and right-hand oxygen saturation. 14% of neonates had below-the-cutoff oxygen saturation in all four extremities, 69.2% of them had abnormal echocardiography too, and 14.8% of all neonates had below-the-cutoff oxygen saturation in three extremities, of which 51% had abnormal echocardiography, as you can see in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The echocardiography results were compared with oxygen saturation in different limbs, and 48.1% of neonates had right-handed oxygen saturation below 95.5%, and among them, 50.8% had abnormal echocardiography.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eCHD stands as a prominent cause of mortality in neonates. Studies indicate an incidence rate of two cases of CHD per 1000 live births (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Out of 35218 neonates, 1% had CHD, and among them, 24% were diagnosed before discharge (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Numerous research works highlight the crucial role of pulse oximetry in CHD identification. Screening with pulse oximetry has emerged as a valuable, non-invasive, and cost-effective strategy (\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Our study is structured on integrating pulse oximetry and echocardiography to enrich the understanding of pulse oximetry's efficacy in CHD detection. Oxygen saturation was measured in the right hand (pre-ductal) and foot (post-ductal). Post-ductal measurement of SpO2 is crucial because defects involving right-to-left shunting of desaturated blood through the ductus arteriosus may go undetected with only preductal measurement.\u003c/p\u003e \u003cp\u003eIn a study on 11233 newborns with exclusion criteria for admission to the NNU unrelated to pulse oximetry. They screened 10,260 newborns with pulse oximetry, finding 23 positive results, including two with critical CHD, 16 with results from an alternative diagnosis, and 5 with normal results. The positive result was due to early screening (2 hours after birth). This study had a sensitivity of 100%, the same as ours, and a specificity of 99.8%, which was much higher than ours. However, while we followed up with echocardiography in all cases in our study, this study followed up with echocardiography only for neonates with critical CHD; this might be a reason for the high specificity of their research (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAccording to a meta-analysis of ten studies, the screening sensitivity was 69.9% to diagnose critical CHD; however, it was very variable, and among those studies, some had a sensitivity of 100%, the same as our study. This study also demonstrates that a cutoff value of approximately 95% can yield the best sensitivity and specificity results, which we also used in our study (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). In another meta-analysis of 13 studies, there was no significant difference between the sensitivity of pulse oximetry in the foot alone or the foot and right hand, which is the same as the result of our study based on the ROC curve. Six of those studies conducted the screening before 24 hours, which could account for the discrepancy. One of the strengths of our study is follow-up with echocardiography, which can give a better picture of the true positive and negative. According to this meta-analysis, there was no significant difference between the sensitivity of pulse oximetry in the foot alone or the foot and right hand, which is the same as the result of our study based on the ROC curve (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). This is while, according to another study, the right foot displayed the highest specificity in pulse oximetry among extremities, the same as our study where the right foot had the highest specificity of 87.5% compared to other extremities. Variability in sensitivity and specificity levels across studies may be due to differences in the timing of measurements. Screening in the first 24 hours of life is less specific than after 24 hours of birth due to hypoxemia, commonly occurring during the transition from intrauterine to extrauterine life conditions (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). In two other studies, screening was implemented within 24 hours with a specificity of 52.4% and 44.22% (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). According to a meta-analysis of 24 cohort studies, there was a significant correlation between maternal diabetes and CHD (odds ratio: 2.65, 95% CI: 2.20\u0026ndash;3.19). However, our study did not investigate maternal diabetes.\u003c/p\u003e \u003cp\u003eNonetheless, we found no significant association between gestational diabetes and CHD (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Other studies found no statistically significant link between neonate gender, weight, delivery techniques, and the mean value of SpO2 and no connection between SpO2 levels and maternal age during pregnancy, gestational diabetes, or preeclampsia, which was reported by our study too (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). In a study on 41647 pregnant women, 215 CHDs were detected, and maternal free thyroxine (FT4) concentration was significantly associated with a higher risk of CHDs (OR:1.04, 95% CI: 1.01\u0026ndash;1.07), which was also reported in our study (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). In this study, over 50% of newborns with SpO2 levels below 95.5% also had abnormal echocardiogram results, providing evidence for the presence of CHD. Furthermore, among newborns with SpO2 levels below 95.5%, a significant majority of 69% exhibited abnormal echocardiogram results, which shows the importance of follow-up with pulse oximetry to estimate more accurate sensitivity and specificity.\u003c/p\u003e\n\u003ch3\u003eLimitation\u003c/h3\u003e\n\u003cp\u003eOur study has particular limitations. One limitation of our study is due to the low prevalence of CHD. To establish an accurate pulse oximetry cutoff, a more extensive study population is required, and this study was conducted at a single-center hospital. However, by performing echocardiography on all neonates, we aim to have a more precise picture of the sensitivity and specificity of the specific cutoff. Another limitation of this study was the absence of following monitoring of infants who exhibited a negative SpO2 upon discharge from the hospital. This study was conducted as a preliminary investigation for a broader study population within the country to assess the significance of pulse oximetry in screening newborns for the detection of CHD.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eIn conclusion, pulse oximetry has proven to be a valuable and non-invasive screening tool for detecting CHD in newborns, exhibiting high sensitivity and specificity. It is crucial to do pulse oximetry within the designated period to guarantee precise outcomes. This study reveals no identifiable link between newborn variables such as gender, weight, Apgar score, and SpO2 level. Furthermore, there is no discernible correlation between pulse oximetry readings and risk factors such as gestational diabetes. The results highlight the role of pulse oximetry and stress its importance in neonatal healthcare.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research has been approved by Shiraz University of Medical Science\u0026apos;s research ethics committees (Approval ID: IR.SUMS.MED.REC.1400.453), ensuring compliance with ethical standards.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll parents agreed and gave consent to participate in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEach author\u0026mdash;B.R., R.M., N.A. (corresponding author), M.A., B.M., R.S.M., and R.M.\u0026mdash;has made significant contributions to the conception, design, data acquisition, analysis, interpretation, software creation, drafting, or revising of the work. B.R. and N.A. significantly contributed to the design of the study and followed up on each step of the study, checking for potential bias and overseeing the data extraction by other authors. R.M. significantly worked in data collection, followed up on the data, edited different parts of the manuscript, prepared figures, and prepared tables. M.A. had a role in data collection, drafting the manuscript, study design, checking for potential errors, revising the manuscript, and preparing tables and figures. B.M., R.S.M., and R.M. contributed to data collection, study design, data analysis, drafting parts of the manuscript, checking for potential errors, and participating in table revision and editing. The submitted version has received approval from all authors, who pledge to take responsibility for their contributions and uphold the integrity of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all the parents who agreed to participate in our study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eTraeger GR, Jaatinen KJ, Majesky MW, Greene CL. The Advent of Spatial Omics in Congenital Heart Disease. Current Treatment Options in Pediatrics. 2023.\u003c/li\u003e\n\u003cli\u003eStout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, et al. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(12):1494-563.\u003c/li\u003e\n\u003cli\u003eMeller CH, Grinenco S, Aiello H, C\u0026oacute;rdoba A, S\u0026aacute;enz-Tejeira MM, Marantz P, et al. Congenital heart disease, prenatal diagnosis and management. Arch Argent Pediatr. 2020;118(2):e149-e61.\u003c/li\u003e\n\u003cli\u003eSong L, Wang Y, Wang H, Wang G, Ma N, Meng Q, et al. Clinical profile of congenital heart diseases detected in a tertiary hospital in China: a retrospective analysis. Front Cardiovasc Med. 2023;10:1131383.\u003c/li\u003e\n\u003cli\u003eArlettaz R, Bauschatz AS, M\u0026ouml;nkhoff M, Essers B, Bauersfeld U. The contribution of pulse oximetry to the early detection of congenital heart disease in newborns. European Journal of Pediatrics. 2006;165(2):94-8.\u003c/li\u003e\n\u003cli\u003eAbu-Harb M, Wyllie J, Hey E, Richmond S, Wren C. Presentation of obstructive left heart malformations in infancy. Arch Dis Child Fetal Neonatal Ed. 1994;71(3):F179-83.\u003c/li\u003e\n\u003cli\u003eMahle WT, Martin GR, Beekman RH, 3rd, Morrow WR. Endorsement of Health and Human Services recommendation for pulse oximetry screening for critical congenital heart disease. Pediatrics. 2012;129(1):190-2.\u003c/li\u003e\n\u003cli\u003eSun R, Liu M, Lu L, Zheng Y, Zhang P. Congenital Heart Disease: Causes, Diagnosis, Symptoms, and Treatments. Cell Biochemistry and Biophysics. 2015;72(3):857-60.\u003c/li\u003e\n\u003cli\u003eEl Idrissi Slitine N, Bennaoui F, Sable CA, Martin GR, Hom LA, Fadel A, et al. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. International Journal of Neonatal Screening. 2020;6(3):53.\u003c/li\u003e\n\u003cli\u003eChang RK, Gurvitz M, Rodriguez S. Missed diagnosis of critical congenital heart disease. Arch Pediatr Adolesc Med. 2008;162(10):969-74.\u003c/li\u003e\n\u003cli\u003eMahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of Pulse Oximetry in Examining Newborns for Congenital Heart Disease. Circulation. 2009;120(5):447-58.\u003c/li\u003e\n\u003cli\u003eManzoni P, Martin GR, Sanchez Luna M, Mestrovic J, Simeoni U, Zimmermann L, et al. Pulse oximetry screening for critical congenital heart defects: a European consensus statement. The Lancet Child \u0026amp; Adolescent Health. 2017;1(2):88-90.\u003c/li\u003e\n\u003cli\u003eMeberg A, Otterstad JE, Fr\u0026oslash;land G, Hals J, S\u0026ouml;rland SJ. Early clinical screening of neonates for congenital heart defects: the cases we miss. Cardiol Young. 1999;9(2):169-74.\u003c/li\u003e\n\u003cli\u003eIlona CN, Nico AB, Andrew KE, Maximo V, Paolo M, Arjan BtP. Aspects of pulse oximetry screening for critical congenital heart defects: when, how and why? Archives of Disease in Childhood - Fetal and Neonatal Edition. 2016;101(2):F162.\u003c/li\u003e\n\u003cli\u003eEwer MS, Yang M, Buzdar AU. Screening for cardiac risk before anthracycline administration: What are the real benefits? Clinical Breast Cancer. 2012;12(1):1-3.\u003c/li\u003e\n\u003cli\u003eMahtab Alam MG, Gowhar Iqbal Wani, Nikhil Gupta. A study to asses pulse oximetry as a screening tool for detecting congenital heart disease. European Journal of Molecular \u0026amp; Clinical Medicine. 2022;9(2):1739-45.\u003c/li\u003e\n\u003cli\u003eHowarth C, Jones AJ, Knowles R, Mat-Ali E, Nicholl R. The impact and efficacy of routine pulse oximetry screening for CHD in a local hospital. Cardiology in the Young. 2016;26(7):1397-405.\u003c/li\u003e\n\u003cli\u003eMahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009;120(5):447-58.\u003c/li\u003e\n\u003cli\u003eThangaratinam S, Brown K, Zamora J, Khan KS, Ewer AK. Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta-analysis. Lancet. 2012;379(9835):2459-64.\u003c/li\u003e\n\u003cli\u003eShenoy KD, Rao SS. Positive predictive value of pulse oximetry in the screening of critical congenital heart defects in term neonates. International Journal of Contemporary Pediatrics. 2017;4:832.\u003c/li\u003e\n\u003cli\u003ePlana MN, Zamora J, Suresh G, Fernandez-Pineda L, Thangaratinam S, Ewer AK. Pulse oximetry screening for critical congenital heart defects. Cochrane Database Syst Rev. 2018;3(3):Cd011912.\u003c/li\u003e\n\u003cli\u003eMathur NB, Gupta A, Kurien S. Pulse Oximetry Screening to Detect Cyanotic Congenital Heart Disease in Sick Neonates in a Neonatal Intensive Care Unit. Indian Pediatr. 2015;52(9):769-72.\u003c/li\u003e\n\u003cli\u003eHu XJ, Zhao QM, Ma XJ, Yan WL, Ge XL, Jia B, et al. Pulse oximetry could significantly enhance the early detection of critical congenital heart disease in neonatal intensive care units. Acta Paediatr. 2016;105(11):e499-e505.\u003c/li\u003e\n\u003cli\u003eWu L, Li N, Liu Y. Association Between Maternal Factors and Risk of Congenital Heart Disease in Offspring: A Systematic Review and Meta-Analysis. Matern Child Health J. 2023;27(1):29-48.\u003c/li\u003e\n\u003cli\u003eMovahedian AH, Mosayebi Z, Sagheb S. Evaluation of Pulse Oximetry in the Early Detection of Cyanotic Congenital Heart Disease in Newborns. J Tehran Heart Cent. 2016;11(2):73-8.\u003c/li\u003e\n\u003cli\u003eHamil\u0026ccedil;ıkan Ş, Can E. Critical congenital heart disease screening with a pulse oximetry in neonates. J Perinat Med. 2018;46(2):203-7.\u003c/li\u003e\n\u003cli\u003eDong J, Peng T, Li MQ, Xie F, Wu JN. Association between Maternal Thyroxine and Risk of Fetal Congenital Heart Defects: A Hospital-Based Cohort Study. Int J Endocrinol. 2022;2022:3859388.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-4565593/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4565593/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground and Objective:\u003c/h2\u003e \u003cp\u003eCongenital heart disease (CHD) is a structural anomaly of the heart that manifests before birth, and it is one of the most prevalent congenital disabilities. The presentations of CHD are heterogeneous and depend on the defect type and age of the neonate. The physical examination and pulse oximetry provide a high level of accuracy, exhibiting a sensitivity of 92% and a specificity of 98% when used together. Some studies showed that pulse oximetry has an influential role in the screening of CHD. However, there are controversial cutoff levels of oxygen saturation as a Reliable screening. This study aims to evaluate the acceptable cutoff of oxygen saturation based on previous guidelines as the primary goal and the prediction of challenges in the screening program of neonates based on the Newborn Health Program.\u003c/p\u003e\u003ch2\u003eMethod\u003c/h2\u003e \u003cp\u003eThis prospective cohort study from September 2021 to June 2022 on 372 neonates with full inclusion criteria and follow-up. The study focused on newborns admitted to the Neonatal Intensive Care Unit (NICU) at Zainabiyeh Hospital, the tertiary referral NICU center south of Iran. The screening was conducted by qualified medical practitioners using pulse oximetry after the first day of admission. Readings above 95.5% were considered negative, while those below 90% were deemed positive. The results were 90% \u0026minus;\u0026thinsp;95.5%; re-evaluate after one hour. In the re-evaluation, if the result was above 95.5%, it was considered negative; if it was below 95.5%, it was considered positive. Echocardiography was conducted within 48 hours for all infants with a positive pulse oximetry result. A bedside echocardiogram was performed before discharge for all neonates. Finally, the echocardiography and pulse oximetry results were compared to evaluate the negative and positive predictive value of pulse oximetry results and cutoff.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAmong 372 neonates, 222 (59%) had a normal echocardiogram, and 150 (41%) had an abnormal echocardiogram. Among neonates with abnormal echocardiography, 96% had acyanotic disease, and more than 50% of babies whose oxygen saturation was less than 95.5% had abnormal echocardiography. Pulse oximetry with a cutoff of 95.5% had 100% sensitivity and a specificity of 84\u0026ndash;87.5% for the diagnosis of CHD. More than 69% of babies with saturation less than 95.5% in all four limbs had an abnormal echocardiogram.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003ePulse oximetry, as the screening tool, can help early detection of neonates with CHD and is also the cost-benefit method in areas lacking tertiary centers for neonatal echocardiography.\u003c/p\u003e","manuscriptTitle":"Role of pulse oximetry for early detection of critical congenital heart disease among the neonates at hospitals affiliated with shiraz university of medical sciences: A pilot study.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-18 18:22:03","doi":"10.21203/rs.3.rs-4565593/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fc101988-86b0-4dd6-86b9-a9a72da08a09","owner":[],"postedDate":"July 18th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-08-16T02:44:50+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-18 18:22:03","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4565593","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4565593","identity":"rs-4565593","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

Text is read by the "Ask this paper" AI Q&A widget below. Extraction quality varies by source — PMC NXML preserves structure cleanly, OA-HTML may include some navigation residue, and OA-PDF can have broken hyphenation. The publisher copy (via DOI) is the canonical version.

My notes (saved in your browser only)

Ask this paper AI returns verbatim quotes from the full text · source: preprint-html

Answers must be backed by verbatim quotes from this paper's full text. Hallucinated quotes are dropped automatically; if no verbatim passage answers the question, we say so. How this works

Citation neighborhood (no data yet)

We don't have any in-corpus citations linked to this paper yet. This is a recent paper (2024) — citers typically take a year or two to land, and the OpenAlex reference graph may still be filling in.

Source provenance

europepmc
last seen: 2026-05-20T01:45:00.602351+00:00