Influence of Biliblanket Treatment on Admission for Overhead Phototherapy in Term Infants Approaching the Treatment Line - A Randomised Controlled Trial

Influence of Biliblanket Treatment on Admission for Overhead Phototherapy in Term Infants Approaching the Treatment Line - A Randomised Controlled Trial | 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 Influence of Biliblanket Treatment on Admission for Overhead Phototherapy in Term Infants Approaching the Treatment Line - A Randomised Controlled Trial Aoife Branagan, Rachel Mullaly, Jana Semberova, Jan Miletin This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8682096/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 Purpose: To evaluate if biliblankets prevents the need for overhead phototherapy in neonates with physiological jaundice approaching the treatment line. Methods: Single-centre randomised trial carried out in a tertiary maternity unit. Infants ≥35 weeks gestation and >24 hours of age with suspected physiological jaundice were eligible if serum bilirubin level was within 35µmol/l of the treatment line. Infants admitted to the neonatal unit or with a positive pre-randomisation direct Coombs test were excluded. Infants were randomised to intervention arm (treatment with Biliblanket) or control arm (routine care). Primary outcome was need for overhead phototherapy. Results: Ninety-seven infants were included in an intention-to-treat analysis, 51 in intervention arm and 46 in control arm with no baseline imbalances. Sixteen percent in the intervention group and 15% in the control group required overhead phototherapy (p>0.99) and no difference in length of stay (p=0.6) was observed. More infants in the intervention arm were discharged receiving formula feeds exclusively (p=0.04) despite no difference in feeding intentions. Conclusion: Use of a biliblanket for physiological jaundice approaching the treatment line in well term infants does not decrease need for overhead phototherapy with no difference in length of stay, but a potential for disruption of breastfeeding establishment. Trial Registration: The trial was retrospectively registered (ISRCTN29045982 - https://www.isrctn.com/) on 08/01/2022. Physiological jaundice phototherapy biliblanket breastfeeding Figures Figure 1 What is Known-What is New Biliblankets have been used in the absence of clinical data, in an effort to avoid the need for overhead phototherapy in well term babies who are approaching the treatment line on bilirubin nomograms, with a potential to have negative impacts including increased length of stay and disruption of feeding. Our study found no difference in need for overhead phototherapy use, or length of stay in infants who were treated with a biliblanket when they were within 35µmol/l of the phototherapy line, with a potential found for disruption of breastfeeding initiation. Infants who are approaching the treatment line for phototherapy should be monitored clinically until they reach the threshold or fall to a safe level. INTRODUCTION Physiological jaundice is a common in healthy term babies who are being cared for in the postnatal wards of maternity hospitals, with about 65% of newborns having a clinically apparent hyperbilirubinemia in the first days of life ( 1 – 3 ). Physiological jaundice occurs due to high levels of circulating unconjugated bilirubin due to accelerated red cell turn-over, reduced handling capacity of bilirubin by the newborn liver and an increased enterohepatic circulation ( 4 ). Between 2 and 10% require treatment to avoid the detrimental consequences related to jaundice, including bilirubin induced brain dysfunction, presenting acutely with poor feeding, lethargy, altered tone, opisthotonos and seizures ( 5 – 9 ). In the longer-term hyperbilirubinemia leads to kernicterus, causing athetoid cerebral palsy and sensorineural hearing loss, which occurs in 0.4 to 2.3 per 100,000 livebirths in high income countries ( 10 – 16 ). Phototherapy converts unconjugated bilirubin to one of its structural isomers, which can be excreted in the urine or stool, bypassing the need for conjugation in the liver ( 17 ). The decision to treat with phototherapy is made when the infant crosses the ‘treatment line’ on a bilirubin nomogram. These nomograms have been created by organisations including the American Academy of Pediatrics (AAP) ( 3 ) and the National Institute for Health and Care Excellence (NICE) in the United Kingdom ( 18 ), and differ slightly based on the chart is chosen. Each allows an increasing level of bilirubin over the first days of life, until a plateau is reached. The level at which this is set varies based on time of life, gestational age, and risk factors for neurotoxicity related to hyperbilirubinaemia including prematurity, haemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency (G6PD) ( 19 , 20 ). Depending on individual unit protocols, treatment with overhead phototherapy can lead to separation of the mother-infant dyad due to necessity for admission to the neonatal unit for treatment. Use of phototherapy may disrupt the initiation of breastfeeding due to mother-infant separation and commonly held beliefs that physiological jaundice may be related to relative dehydration ( 21 ). Phototherapy may also increase hospital length of stay ( 21 ). ‘Biliblankets’ are light-emitting diode (LED) or fibreoptic lights which can be placed beside the skin, inside the infants clothing. They were designed initially as adjuvants or replacements for overhead lights. In many units they can be used for either home treatment, or on the postnatal wards, in an effort to prevent mother-infant separation for phototherapy ( 22 ). One approach used to decrease the need for neonatal unit admission for overhead phototherapy in healthy term babies, is to commence a biliblanket on the wards in infants who are approaching but have not reached the treatment line on the relevant bilirubin nomogram. However little data exists to support this indication. To date no randomised control trial (RCT) has assessed the utility of the biliblanket for prevention of the need for phototherapy in term infants approaching the phototherapy line for their age. We hypothesised that using ‘Biliblanket’ in infants approaching the treatment line for phototherapy would decrease phototherapy use, leading to less separation of mother and infant. METHODS Study Design A single centre RCT was carried out in the postnatal wards of a level III maternity unit, The Coombe Hospital, Dublin, Ireland. The trial protocol was registered (ISRCTN29045982 - https://www.isrctn.com/ ). Ethical approval was granted by the research ethics committee of The Coombe Hospital (REC 21-2020). Written informed consent was obtained from the parents/guardians of each infant prior to enrolment in the trial. Participants Infants were eligible for inclusion in the study if they were > 24 hours of age, and ≥ 35 weeks of gestation with a clinical diagnosis of suspected physiological jaundice, if they had a serum bilirubin taken less than 35 umol/l from the phototherapy line for their age of life. Infants were excluded if they developed jaundice in the first 24 hours of life, if they had been admitted to the neonatal intensive care unit for any reason or if they were known to be direct Coombs test (DCT) positive at the time of enrolment. Infants who were later found to be DCT positive after undergoing investigation of their jaundice were included in the intention to treat analysis. Decision to recruit to the study was based on the bilirubin nomogram which is currently in use in The Coombe Hospital (supplementary Fig. 1). A chart detailing which number was acceptable for recruitment and phototherapy treatment was developed from the chart to ensure no ambiguity. Randomisation and Masking Computer generated randomisation was performed, using random permuted blocks of 8 to assign infants in a 1:1 allocation ratio to the intervention arm (treatment with a biliblanket) or control arm (no biliblanket treatment). Randomisation was stratified by gestational age, 35–37 weeks gestation at birth, and greater than 37 weeks gestation. The randomisation schedule was made by a research coordinator with no clinical involvement in the trial. Sealed, opaque, sequentially numbered envelopes were used to conceal group assignment prior to randomisation and stored centrally in the neonatal unit. Due to the nature of the intervention, neither caregiver nor outcome assessors could not be blinded to the assigned group. Study Procedure When an infant had a serum bilirubin result which was less than 35 umol/l from the treatment line for their age, parents were approached for informed consent. Transcutaneous bilirubin was not allowable for study entry; however, a transcutaneous measurement could trigger a serum bilirubin as per hospital protocol. On receipt of informed parental consent infants were randomised to the intervention or control arm of the trial. Infants who were randomised to the intervention arm were treated with a biliblanket on the post-natal ward. There were two systems in use during the trial – ‘Biliblanket plus high output phototherapy system - CE0086’ (Ohmeda Medical, Wisconsin, USA, CE0086) and ‘Bili-Therapy Pad type - CE0123’ (ATOM Medical, Tokyo, Japan). Infants in the control arm were treated with standard care (no biliblanket treatment). Infants in both groups had serum bilirubin levels monitored every 12 hours until they required overheard phototherapy treatment on the bilirubin nomogram or they reach a safe level for their age and gestation when monitoring was then discontinued. A safe level was defined as serum bilirubin level 50umol/l or further from the treatment line. Infants in the intervention arm had a rebound sample taken eight hours after discontinuation of the blanket. Study Endpoints The primary outcome of the study was the need for overhead phototherapy treatment (binary). Secondary outcomes were the length of hospital stay after birth and the feeding outcomes including the successful establishment of breastfeeding by hospital discharge. Sample Size Calculation Sample size calculation was based on a retrospective chart review of infants who had serum bilirubin levels measured on the post-natal ward over a two-month period. Over this period 31 infants had serum bilirubin level less than 35umol/l under the treatment line for their age. Thirty five percent of these required phototherapy. Assuming a minimally important clinical difference of 25% (and reducing need for overhead phototherapy to 10% of these infants). To detect above mentioned difference between intervention and control groups with 80% power and alpha of 0.05, 51 patients would be required in each arm (Fisher’s Exact Test). Statistical Analysis Data was collected in Excel (Microsoft, USA). Statistical analysis was performed using StatsDirect v.3.3.5 (StatsDirect Ltd, Cheshire, UK). We compared normally distributed continuous variables with t tests and compared dichotomous and categorical variables with non-parametric tests (χ2 test, Mann-Whitney U test, Fisher’s exact test). Data is presented as median (interquartile range (IQR)), mean (standard deviation (SD)) and 95% confidence intervals (CI) as appropriate. RESULTS Enrolment Patient flow through the study is detailed in Fig. 1 . Over the two-year enrolment period (August 2020 to August 2022) 110 infants met the eligibility criteria for the study. Of these, seven declined to consent for trial enrolment, in two cases a physician decided to treat with biliblanket outside the trial, two had previously been treated with intravenous (IV) fluids and for two no information was available. Ninety-seven infants were randomised, 51 to the intervention arm and 46 to the control arm. All randomised infants were included in an intention to treat analysis. Patient Characteristics Patient characteristics at baseline were similar between the intervention and control groups. In the control group infants had a mean (standard deviation (SD)) gestational age of 39 (1.5) weeks with mean (SD) birth weight of 3.3 (0.4) kg. In the intervention group mean (SD) gestation was 39 (1.4) weeks with a mean birth weight of 3.3 (0.5) kg. In the control arm 52% were male compared to 51% of the intervention arm. Apgar scores in both groups were a median (interquartile range (IQR)) of 9 (0) and 10 (0) at 1 and 5 minutes of life respectively. Further details are shown in Table 1 . At study entry, infants in the control group were a median (IQR) of 38 ( 17 ) hours compared to 41 ( 18 ) hours in the intervention arm. Infants in the control group were a median (IQR) of 23 ( 17 ) umol/l from the phototherapy treatment line at study entry compared to 18 ( 14 ) umol/l in the intervention arm. Infants in the intervention arm spent a median (IQR) of 16 ( 12 ) hours on treatment with a biliblanket (Table 2 ). Regarding DCT status, two infants in the control arm were found to be positive after investigation after recruitment to the study, one with ABO isoimmunisation and one with anti-S antibodies (MNS antigen system), compared to one infant in the intervention arm with anti-Jk antibodies (Kidd antigen system). Primary Outcomes The primary outcome, requirement for overhead phototherapy treatment, was measured in all participants and did not show a statistically significant difference. In the intervention group eight infants (16%) needed phototherapy, while in the control group seven infants (15%) required phototherapy (p > .99). See Table 3 for further details. Table 3 Primary Outcome. IQR, Interquartile Range. Control (n = 46) Intervention (n = 51) P value Required Phototherapy, n (%) 7 ( 15 ) 8 ( 16 ) > 0.99 Time on phototherapy, median (IQR) hours 18 ( 8 ) 19 ( 10 ) 0.88 Length of hospital stay, median (IQR) days 4 ( 1 ) 4 ( 1 ) 0.6 Infants in the intervention group spent a median (IQR) of 19 ( 10 ) hours on phototherapy, compared to 18 ( 8 ) hours in the control group (p = 0.88). Overall hospital length of stay, including in the neonatal unit and postnatal ward also did not differ between groups, at a median (IQR) of 4 ( 1 ) days in both groups (p = 0.6) (Table 3 ). Secondary Outcomes Secondary outcomes assessed phototherapy duration, hospital length of stay and feeding outcomes for infants included in the study. We found a statistically significant difference for maximal weight loss between groups. Infants in the intervention group lost at peak 5.1% of their birth weight, compared to 3.7% in the control group (p = 0.02). The absolute weight loss in grams was not significantly different (Table 4 ). When questioned at birth, 65% of the control group, and 73% of the intervention group planned to breastfeed their infant. At discharge from hospital 13% of the control group were exclusively breastfeeding compared to 4% of the intervention group (p = 0.12). There was a statistically significant difference in percentage of infants receiving formula only – 73% of the intervention group compared to 52% of the control group (p = 0.04). Overall, high numbers in both groups received formula at some point during their admission – 87% of the control group and 96% of the intervention group, with no statistically significant difference between groups (Table 4 ). DISCUSSION Our randomised trial of 97 well near term and term babies, with physiological jaundice approaching the treatment line found no difference in the primary outcome of requirement for overhead phototherapy with the use of biliblankets. While our secondary outcomes showed that use of biliblankets did not increase the length of stay, we found a significant difference in weight loss between groups (5.1% in the intervention group compared to 3.7% in the control group) and also a decreased level of breast feeding in the intervention group. While the overall level of weight loss is low and therefore unlikely to be clinically significant, the disruption of establishment of breast feeding by the use of biliblankets may be clinically plausible. LED or fibreoptic lights, known as biliblankets, were designed as replacements or adjuvants to phototherapy. In many units they can be used for either home treatment, or on the postnatal wards, in an effort to prevent mother-infant separation for phototherapy. While some studies have shown that they may be as effective as conventional phototherapy in the treatment of hyperbilirubinaemia, while decreasing the potential complications, a Cochrane review has shown fibreoptic lights to be less effective than conventional phototherapy, but more effective than no treatment, although it was equally effective in preterm infants ( 23 – 26 ). A combination of conventional with fibreoptic phototherapy was the most effective strategy. No trials within the Cochrane review were identified to support the commonly held view that fiberoptic devices interfere less with infant care and parent-child bonding than traditional phototherapy ( 22 ). The efficacy of any device in the treatment of neonatal jaundice is dependent on multiple factors including light intensity, surface area exposure, and treatment duration. To date, there is very little evidence on the utility of biliblankets to avoid need for phototherapy. A study by Orringer et al in 2023 assessed home treatment of jaundice using biliblankets in those who had a reading between 17 and 50umol/l from the AAP treatment line, using a retrospective chart review ( 27 ). Of those at this threshold, 44% of infants had home treatment with a biliblanket. Four percent (n = 6) of newborns treated with biliblanket were readmitted compared with 13% (n = 26) of those not initially treated with a biliblanket (p= .002), suggesting that the use of biliblankets to avoid overhead phototherapy may be successful. To our knowledge, our study is the first to evaluate this strategy in a randomised controlled trial. While phototherapy is safe and effective in the treatment of neonatal jaundice some potential complications exist including insensible water loss, thermoregulatory instability, bronze baby syndrome, and retinal injury. Long term adverse events of phototherapy include an increased risk of seizures, especially in males ( 28 ) and suggestions of a potential small increased risk of cancer including leukaemia, renal and hepatic at a rate of 1 per 10,000 treated newborns ( 29 – 31 ). The risk of adverse events related to phototherapy needs to be weighed with the risks of jaundice itself, however, our results strongly support avoiding the initiation of infants who have not yet reached the treatment threshold on phototherapy, as ultimately only 15% of those who came within 35umol/l of the treatment line required phototherapy while continuing to be monitored. In this study, relatively low numbers planned on initiating breast feeding after delivery, 65% in the control group and 73% in the intervention group, although these are in line with national numbers ( 32 ). The successful initiation of breast-feeding during hospital stay was very low overall, with only 8% of those recruited to the study discharged exclusively feeding by breast, with a further 29% combination feeding. This is far lower than the overall numbers of women breastfeeding in Ireland at discharge from hospital, which is quoted at 46%, with a further 15.7% combination feeding ( 33 ). This highlights the vulnerable nature of this population where exclusive breastfeeding and ‘dehydration’ may be blamed for the onset of physiological jaundice, and suggestions that the initiation of formula may avoid phototherapy need in the days after birth. These results are supported by other studies which showed infants with jaundice were twice as likely to have stopped breastfeeding at one month than infants without jaundice ( 34 , 35 ). Positive interactions and encouragement from healthcare professionals that breastfeeding despite jaundice is possible were one of the strongest predictors of successful breastfeeding. Only 8% of infants in our study did not receive any formula while an in-patient. While the use of biliblankets in our institution is in an effort to promote keeping the mother-infant dyad together and support breastfeeding, it seems use of biliblankets was a further risk factor in disruption of breast feeding. There was a statistically significant difference between groups in the number of infants receiving only formula at discharge (52% in the control group compared to 73% in the intervention group, p = 0.04). There were non-significant differences seen in infants exclusively breastfeeding at discharge (13% in control group vs 4% in the intervention group, p = 0.12) and infants receiving combination feeding at discharge (35% in the control group compared to 24% in the intervention group). While our study was not powered to detect differences in infant feeding, these numbers suggest that use of the biliblanket disrupted establishment of breastfeeding in an already vulnerable group, likely due to the cumbersome nature of caring for an infant on a biliblanket in the postnatal ward, and the fear of needing phototherapy and separation if the intervention failed. Our study had several strengths, including the randomised nature and the pragmatic design, carried out on the postnatal wards of a busy tertiary maternity unit. We also had some limitations. We were underpowered in the control arm, which is likely attributable to Pragmatic trial design on postnatal ward. The level of the primary outcome seen in both groups was less than expected in our initial power calculation. This may be because the initiation of the study created a guideline for the treatment of infants who were nearing the treatment, where previously they may have been commenced on phototherapy. In line with our pragmatic design we continued to use the bilirubin nomogram which is in use in our institution rather than change to one of the more well-known graphs, such as the AAP or NICE guidelines. This may limit the generalisability of our results. Conclusion Our results suggest that the use of a ‘Biliblanket’ to treat physiological jaundice approaching the treatment line in well term infants does not decrease need for overhead phototherapy with no difference in length of stay, and a potential for disruption of breastfeeding establishment, and therefore consideration should be given to discontinuing their use in this clinical scenario. Our results also suggests that phototherapy treatment should only be started when infants cross the phototherapy line, rather than when approaching, as the numbers ultimately needing treatment are low. Abbreviations LED – light-emitting diode AAP - American Academy of Pediatrics NICE - National Institute for Health and Care Excellence G6PD - 6-phosphate dehydrogenase deficiency RCT - Randomised control trial DCT - Direct Coombs test IV - intravenous SD - Standard Deviation IQR - Interquartile range Declarations Role of funding: No funding support was received for this project. Conflict of interest statement: The authors have no conflicts of interest to disclose related to this project. Data availability statement: Data from the below study will be available from the authors on reasonable request Author Contributions: AB, RM, JM and JS conceived and designed the study. AB and RM recruited participants and collected data. AB and JM performed the data analysis. AB drafted the initial manuscript. All authors critically revised the manuscript for important intellectual content and reviewed and approved the final version of the manuscript. Ethical approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of The Coombe Hospital, (REC 21-2020) in June 2020. Consent to participate: Written informed consent was obtained from the parents/guardians of all participants. References Keren R, Luan X, Friedman S, Saddlemire S, Cnaan A, Bhutani VK (2008) A comparison of alternative risk-assessment strategies for predicting significant neonatal hyperbilirubinemia in term and near-term infants. Pediatrics 121(1):e170–e179 Maisels MJ, McDonagh AF (2008) Phototherapy for neonatal jaundice. N Engl J Med 358(9):920–928 Management of hyperbilirubinemia (2004) in the newborn infant 35 or more weeks of gestation. 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Epilepsy Res 124:67–72 Wickremasinghe AC, Kuzniewicz MW, Grimes BA, McCulloch CE, Newman TB (2016) Neonatal Phototherapy and Infantile Cancer. Pediatrics. ;137(6) Newman TB, Wickremasinghe AC, Walsh EM, Grimes BA, McCulloch CE, Kuzniewicz MW (2016) Retrospective Cohort Study of Phototherapy and Childhood Cancer in Northern California. Pediatrics. ;137(6) Auger N, Laverdière C, Ayoub A, Lo E, Luu TM (2019) Neonatal phototherapy and future risk of childhood cancer. Int J Cancer 145(8):2061–2069 Health Service Executive I Breastfeeding in a Healthy Ireland – Health Service Executive Action Plan 2016–2021* Implementation progress report Ireland 2024 [ Health Service Executive I Perinatal Statistics Report 2021 Ireland 2021 [ Willis SK, Hannon PR, Scrimshaw SC (2002) The impact of the maternal experience with a jaundiced newborn on the breastfeeding relationship. J Fam Pract 51(5):465 Kemper K, Forsyth B, McCarthy P (1989) Jaundice, terminating breast-feeding, and the vulnerable child. Pediatrics 84(5):773–778 Table 1 and 2, 4 Table 1 and 2, 4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Supplementaryfigure1.png Supplementary Figure 1. Bilirubin nomogram used to decide on study entry and use of phototherapy. Table124.docx 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-8682096","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":584492890,"identity":"70330cd0-2b34-4abe-b28d-b68898163fe7","order_by":0,"name":"Aoife Branagan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAwUlEQVRIiWNgGAWjYBACexiDH4glGAyI0GLYAGVIthGrxeAAjHEMpIUYYDj78LMHP37ZyRvfb354g6HAhrAWe740c8PevmTDbcfYjC0YDNKIsKWHwUyCt4eZcdsxHjagXw4T1mJwhv2b5N+eevvNbWAt/4nRwmMmzfPjcOIGNrCWA8Q4jKdMWrbhePKMY2nGFgkGyYS12POwb5N886fatr/58MMbH/7YEdYCBoxtUEYCkRqA4A/xSkfBKBgFo2AEAgBF+DU0stmXXAAAAABJRU5ErkJggg==","orcid":"","institution":"Coombe Women \u0026 Infants University Hospital","correspondingAuthor":true,"prefix":"","firstName":"Aoife","middleName":"","lastName":"Branagan","suffix":""},{"id":584492891,"identity":"00fc0ef9-5520-4a48-8dd9-274f21f24879","order_by":1,"name":"Rachel Mullaly","email":"","orcid":"","institution":"Coombe Women \u0026 Infants University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Rachel","middleName":"","lastName":"Mullaly","suffix":""},{"id":584492893,"identity":"d1cdc814-86d6-4f2e-a529-a9bca118a1f9","order_by":2,"name":"Jana Semberova","email":"","orcid":"","institution":"Coombe Women \u0026 Infants University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jana","middleName":"","lastName":"Semberova","suffix":""},{"id":584492895,"identity":"972dc709-6808-438e-a142-0e64b0a87c8a","order_by":3,"name":"Jan Miletin","email":"","orcid":"","institution":"Coombe Women \u0026 Infants University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jan","middleName":"","lastName":"Miletin","suffix":""}],"badges":[],"createdAt":"2026-01-23 19:23:45","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8682096/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8682096/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":101792556,"identity":"76850ef0-8c6d-4dc2-aad7-b8459a1eacab","added_by":"auto","created_at":"2026-02-03 16:12:49","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":43777,"visible":true,"origin":"","legend":"\u003cp\u003eConsort flow diagram\u003c/p\u003e","description":"","filename":"Figure1PNG.png","url":"https://assets-eu.researchsquare.com/files/rs-8682096/v1/1878ae12d2b44802884e3953.png"},{"id":104125030,"identity":"3c659590-8412-4ab1-8c39-35441d9ee2d3","added_by":"auto","created_at":"2026-03-07 09:25:38","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":603660,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8682096/v1/79bc17bc-1a4d-4b78-bb88-d8c83ba284dd.pdf"},{"id":101792449,"identity":"1d26d91b-b5f1-4495-9ab2-90031fc5326e","added_by":"auto","created_at":"2026-02-03 16:12:29","extension":"png","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":389742,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary Figure 1. Bilirubin nomogram used to decide on study entry and use of phototherapy.\u003c/p\u003e","description":"","filename":"Supplementaryfigure1.png","url":"https://assets-eu.researchsquare.com/files/rs-8682096/v1/9f91c4981bfdc2049e00a070.png"},{"id":101792535,"identity":"716b4363-9796-4ff1-8536-64582a163dbe","added_by":"auto","created_at":"2026-02-03 16:12:44","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":17306,"visible":true,"origin":"","legend":"","description":"","filename":"Table124.docx","url":"https://assets-eu.researchsquare.com/files/rs-8682096/v1/3fae0b585357e67cb254a59c.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Influence of Biliblanket Treatment on Admission for Overhead Phototherapy in Term Infants Approaching the Treatment Line - A Randomised Controlled Trial","fulltext":[{"header":"What is Known-What is New","content":"\u003cul\u003e\n \u003cli\u003eBiliblankets have been used in the absence of clinical data, in an effort to avoid the need for overhead phototherapy in well term babies who are approaching the treatment line on bilirubin nomograms, with a potential to have negative impacts including increased length of stay and disruption of feeding.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eOur study found no difference in need for overhead phototherapy use, or length of stay in infants who were treated with a biliblanket when they were within 35\u0026micro;mol/l of the phototherapy line, with a potential found for disruption of breastfeeding initiation.\u003c/li\u003e\n \u003cli\u003eInfants who are approaching the treatment line for phototherapy should be monitored clinically until they reach the threshold or fall to a safe level.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003ePhysiological jaundice is a common in healthy term babies who are being cared for in the postnatal wards of maternity hospitals, with about 65% of newborns having a clinically apparent hyperbilirubinemia in the first days of life (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Physiological jaundice occurs due to high levels of circulating unconjugated bilirubin due to accelerated red cell turn-over, reduced handling capacity of bilirubin by the newborn liver and an increased enterohepatic circulation (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Between 2 and 10% require treatment to avoid the detrimental consequences related to jaundice, including bilirubin induced brain dysfunction, presenting acutely with poor feeding, lethargy, altered tone, opisthotonos and seizures (\u003cspan additionalcitationids=\"CR6 CR7 CR8\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). In the longer-term hyperbilirubinemia leads to kernicterus, causing athetoid cerebral palsy and sensorineural hearing loss, which occurs in 0.4 to 2.3 per 100,000 livebirths in high income countries (\u003cspan additionalcitationids=\"CR11 CR12 CR13 CR14 CR15\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Phototherapy converts unconjugated bilirubin to one of its structural isomers, which can be excreted in the urine or stool, bypassing the need for conjugation in the liver (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe decision to treat with phototherapy is made when the infant crosses the \u0026lsquo;treatment line\u0026rsquo; on a bilirubin nomogram. These nomograms have been created by organisations including the American Academy of Pediatrics (AAP) (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) and the National Institute for Health and Care Excellence (NICE) in the United Kingdom (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), and differ slightly based on the chart is chosen. Each allows an increasing level of bilirubin over the first days of life, until a plateau is reached. The level at which this is set varies based on time of life, gestational age, and risk factors for neurotoxicity related to hyperbilirubinaemia including prematurity, haemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency (G6PD) (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDepending on individual unit protocols, treatment with overhead phototherapy can lead to separation of the mother-infant dyad due to necessity for admission to the neonatal unit for treatment. Use of phototherapy may disrupt the initiation of breastfeeding due to mother-infant separation and commonly held beliefs that physiological jaundice may be related to relative dehydration (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Phototherapy may also increase hospital length of stay (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). \u0026lsquo;Biliblankets\u0026rsquo; are light-emitting diode (LED) or fibreoptic lights which can be placed beside the skin, inside the infants clothing. They were designed initially as adjuvants or replacements for overhead lights. In many units they can be used for either home treatment, or on the postnatal wards, in an effort to prevent mother-infant separation for phototherapy (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOne approach used to decrease the need for neonatal unit admission for overhead phototherapy in healthy term babies, is to commence a biliblanket on the wards in infants who are approaching but have not reached the treatment line on the relevant bilirubin nomogram. However little data exists to support this indication. To date no randomised control trial (RCT) has assessed the utility of the biliblanket for prevention of the need for phototherapy in term infants approaching the phototherapy line for their age. We hypothesised that using \u0026lsquo;Biliblanket\u0026rsquo; in infants approaching the treatment line for phototherapy would decrease phototherapy use, leading to less separation of mother and infant.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eA single centre RCT was carried out in the postnatal wards of a level III maternity unit, The Coombe Hospital, Dublin, Ireland. The trial protocol was registered (ISRCTN29045982 - \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.isrctn.com/\u003c/span\u003e\u003cspan address=\"https://www.isrctn.com/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). Ethical approval was granted by the research ethics committee of The Coombe Hospital (REC 21-2020). Written informed consent was obtained from the parents/guardians of each infant prior to enrolment in the trial.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eInfants were eligible for inclusion in the study if they were \u0026gt;\u0026thinsp;24 hours of age, and \u0026ge;\u0026thinsp;35 weeks of gestation with a clinical diagnosis of suspected physiological jaundice, if they had a serum bilirubin taken less than 35 umol/l from the phototherapy line for their age of life. Infants were excluded if they developed jaundice in the first 24 hours of life, if they had been admitted to the neonatal intensive care unit for any reason or if they were known to be direct Coombs test (DCT) positive at the time of enrolment. Infants who were later found to be DCT positive after undergoing investigation of their jaundice were included in the intention to treat analysis. Decision to recruit to the study was based on the bilirubin nomogram which is currently in use in The Coombe Hospital (supplementary Fig.\u0026nbsp;1). A chart detailing which number was acceptable for recruitment and phototherapy treatment was developed from the chart to ensure no ambiguity.\u003c/p\u003e\n\u003ch3\u003eRandomisation and Masking\u003c/h3\u003e\n\u003cp\u003eComputer generated randomisation was performed, using random permuted blocks of 8 to assign infants in a 1:1 allocation ratio to the intervention arm (treatment with a biliblanket) or control arm (no biliblanket treatment). Randomisation was stratified by gestational age, 35\u0026ndash;37 weeks gestation at birth, and greater than 37 weeks gestation. The randomisation schedule was made by a research coordinator with no clinical involvement in the trial. Sealed, opaque, sequentially numbered envelopes were used to conceal group assignment prior to randomisation and stored centrally in the neonatal unit. Due to the nature of the intervention, neither caregiver nor outcome assessors could not be blinded to the assigned group.\u003c/p\u003e\n\u003ch3\u003eStudy Procedure\u003c/h3\u003e\n\u003cp\u003eWhen an infant had a serum bilirubin result which was less than 35 umol/l from the treatment line for their age, parents were approached for informed consent. Transcutaneous bilirubin was not allowable for study entry; however, a transcutaneous measurement could trigger a serum bilirubin as per hospital protocol. On receipt of informed parental consent infants were randomised to the intervention or control arm of the trial. Infants who were randomised to the intervention arm were treated with a biliblanket on the post-natal ward. There were two systems in use during the trial \u0026ndash; \u0026lsquo;Biliblanket plus high output phototherapy system - CE0086\u0026rsquo; (Ohmeda Medical, Wisconsin, USA, CE0086) and \u0026lsquo;Bili-Therapy Pad type - CE0123\u0026rsquo; (ATOM Medical, Tokyo, Japan). Infants in the control arm were treated with standard care (no biliblanket treatment). Infants in both groups had serum bilirubin levels monitored every 12 hours until they required overheard phototherapy treatment on the bilirubin nomogram or they reach a safe level for their age and gestation when monitoring was then discontinued. A safe level was defined as serum bilirubin level 50umol/l or further from the treatment line. Infants in the intervention arm had a rebound sample taken eight hours after discontinuation of the blanket.\u003c/p\u003e\n\u003ch3\u003eStudy Endpoints\u003c/h3\u003e\n\u003cp\u003eThe primary outcome of the study was the need for overhead phototherapy treatment (binary). Secondary outcomes were the length of hospital stay after birth and the feeding outcomes including the successful establishment of breastfeeding by hospital discharge.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eSample Size Calculation\u003c/h2\u003e \u003cp\u003e Sample size calculation was based on a retrospective chart review of infants who had serum bilirubin levels measured on the post-natal ward over a two-month period. Over this period 31 infants had serum bilirubin level less than 35umol/l under the treatment line for their age. Thirty five percent of these required phototherapy. Assuming a minimally important clinical difference of 25% (and reducing need for overhead phototherapy to 10% of these infants). To detect above mentioned difference between intervention and control groups with 80% power and alpha of 0.05, 51 patients would be required in each arm (Fisher\u0026rsquo;s Exact Test).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eData was collected in Excel (Microsoft, USA). Statistical analysis was performed using StatsDirect v.3.3.5 (StatsDirect Ltd, Cheshire, UK). We compared normally distributed continuous variables with t tests and compared dichotomous and categorical variables with non-parametric tests (χ2 test, Mann-Whitney U test, Fisher\u0026rsquo;s exact test). Data is presented as median (interquartile range (IQR)), mean (standard deviation (SD)) and 95% confidence intervals (CI) as appropriate.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eEnrolment\u003c/h2\u003e\n \u003cp\u003ePatient flow through the study is detailed in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. Over the two-year enrolment period (August 2020 to August 2022) 110 infants met the eligibility criteria for the study. Of these, seven declined to consent for trial enrolment, in two cases a physician decided to treat with biliblanket outside the trial, two had previously been treated with intravenous (IV) fluids and for two no information was available. Ninety-seven infants were randomised, 51 to the intervention arm and 46 to the control arm. All randomised infants were included in an intention to treat analysis.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003ePatient Characteristics\u003c/h2\u003e\n \u003cp\u003ePatient characteristics at baseline were similar between the intervention and control groups. In the control group infants had a mean (standard deviation (SD)) gestational age of 39 (1.5) weeks with mean (SD) birth weight of 3.3 (0.4) kg. In the intervention group mean (SD) gestation was 39 (1.4) weeks with a mean birth weight of 3.3 (0.5) kg. In the control arm 52% were male compared to 51% of the intervention arm. Apgar scores in both groups were a median (interquartile range (IQR)) of 9 (0) and 10 (0) at 1 and 5 minutes of life respectively. Further details are shown in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003cp\u003eAt study entry, infants in the control group were a median (IQR) of 38 (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e) hours compared to 41 (\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e) hours in the intervention arm. Infants in the control group were a median (IQR) of 23 (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e) umol/l from the phototherapy treatment line at study entry compared to 18 (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e) umol/l in the intervention arm. Infants in the intervention arm spent a median (IQR) of 16 (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e) hours on treatment with a biliblanket (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eRegarding DCT status, two infants in the control arm were found to be positive after investigation after recruitment to the study, one with ABO isoimmunisation and one with anti-S antibodies (MNS antigen system), compared to one infant in the intervention arm with anti-Jk antibodies (Kidd antigen system).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003ePrimary Outcomes\u003c/h2\u003e\n \u003cp\u003eThe primary outcome, requirement for overhead phototherapy treatment, was measured in all participants and did not show a statistically significant difference. In the intervention group eight infants (16%) needed phototherapy, while in the control group seven infants (15%) required phototherapy (p \u0026gt; .99). See Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e for further details.\u003c/p\u003e\n \u003cdiv\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003ePrimary Outcome. IQR, Interquartile Range.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eControl (n\u0026thinsp;=\u0026thinsp;46)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eIntervention (n\u0026thinsp;=\u0026thinsp;51)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRequired Phototherapy, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7 (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8 (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u0026gt;\u0026thinsp;0.99\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTime on phototherapy, median (IQR) hours\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18 (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e19 (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.88\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eLength of hospital stay, median (IQR) days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eInfants in the intervention group spent a median (IQR) of 19 (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e) hours on phototherapy, compared to 18 (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) hours in the control group (p\u0026thinsp;=\u0026thinsp;0.88). Overall hospital length of stay, including in the neonatal unit and postnatal ward also did not differ between groups, at a median (IQR) of 4 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) days in both groups (p\u0026thinsp;=\u0026thinsp;0.6) (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003eSecondary Outcomes\u003c/h2\u003e\n \u003cp\u003eSecondary outcomes assessed phototherapy duration, hospital length of stay and feeding outcomes for infants included in the study.\u003c/p\u003e\n \u003cp\u003eWe found a statistically significant difference for maximal weight loss between groups. Infants in the intervention group lost at peak 5.1% of their birth weight, compared to 3.7% in the control group (p\u0026thinsp;=\u0026thinsp;0.02). The absolute weight loss in grams was not significantly different (Table \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv\u003eWhen questioned at birth, 65% of the control group, and 73% of the intervention group planned to breastfeed their infant. At discharge from hospital 13% of the control group were exclusively breastfeeding compared to 4% of the intervention group (p\u0026thinsp;=\u0026thinsp;0.12). There was a statistically significant difference in percentage of infants receiving formula only \u0026ndash; 73% of the intervention group compared to 52% of the control group (p\u0026thinsp;=\u0026thinsp;0.04). Overall, high numbers in both groups received formula at some point during their admission \u0026ndash; 87% of the control group and 96% of the intervention group, with no statistically significant difference between groups (Table \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/div\u003e\n\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eOur randomised trial of 97 well near term and term babies, with physiological jaundice approaching the treatment line found no difference in the primary outcome of requirement for overhead phototherapy with the use of biliblankets. While our secondary outcomes showed that use of biliblankets did not increase the length of stay, we found a significant difference in weight loss between groups (5.1% in the intervention group compared to 3.7% in the control group) and also a decreased level of breast feeding in the intervention group. While the overall level of weight loss is low and therefore unlikely to be clinically significant, the disruption of establishment of breast feeding by the use of biliblankets may be clinically plausible.\u003c/p\u003e \u003cp\u003eLED or fibreoptic lights, known as biliblankets, were designed as replacements or adjuvants to phototherapy. In many units they can be used for either home treatment, or on the postnatal wards, in an effort to prevent mother-infant separation for phototherapy. While some studies have shown that they may be as effective as conventional phototherapy in the treatment of hyperbilirubinaemia, while decreasing the potential complications, a Cochrane review has shown fibreoptic lights to be less effective than conventional phototherapy, but more effective than no treatment, although it was equally effective in preterm infants (\u003cspan additionalcitationids=\"CR24 CR25\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). A combination of conventional with fibreoptic phototherapy was the most effective strategy. No trials within the Cochrane review were identified to support the commonly held view that fiberoptic devices interfere less with infant care and parent-child bonding than traditional phototherapy (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). The efficacy of any device in the treatment of neonatal jaundice is dependent on multiple factors including light intensity, surface area exposure, and treatment duration.\u003c/p\u003e \u003cp\u003eTo date, there is very little evidence on the utility of biliblankets to avoid need for phototherapy. A study by Orringer et al in 2023 assessed home treatment of jaundice using biliblankets in those who had a reading between 17 and 50umol/l from the AAP treatment line, using a retrospective chart review (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Of those at this threshold, 44% of infants had home treatment with a biliblanket. Four percent (n\u0026thinsp;=\u0026thinsp;6) of newborns treated with biliblanket were readmitted compared with 13% (n\u0026thinsp;=\u0026thinsp;26) of those not initially treated with a biliblanket (p= .002), suggesting that the use of biliblankets to avoid overhead phototherapy may be successful. To our knowledge, our study is the first to evaluate this strategy in a randomised controlled trial.\u003c/p\u003e \u003cp\u003eWhile phototherapy is safe and effective in the treatment of neonatal jaundice some potential complications exist including insensible water loss, thermoregulatory instability, bronze baby syndrome, and retinal injury. Long term adverse events of phototherapy include an increased risk of seizures, especially in males (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e) and suggestions of a potential small increased risk of cancer including leukaemia, renal and hepatic at a rate of 1 per 10,000 treated newborns (\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). The risk of adverse events related to phototherapy needs to be weighed with the risks of jaundice itself, however, our results strongly support avoiding the initiation of infants who have not yet reached the treatment threshold on phototherapy, as ultimately only 15% of those who came within 35umol/l of the treatment line required phototherapy while continuing to be monitored.\u003c/p\u003e \u003cp\u003eIn this study, relatively low numbers planned on initiating breast feeding after delivery, 65% in the control group and 73% in the intervention group, although these are in line with national numbers (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). The successful initiation of breast-feeding during hospital stay was very low overall, with only 8% of those recruited to the study discharged exclusively feeding by breast, with a further 29% combination feeding. This is far lower than the overall numbers of women breastfeeding in Ireland at discharge from hospital, which is quoted at 46%, with a further 15.7% combination feeding (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). This highlights the vulnerable nature of this population where exclusive breastfeeding and \u0026lsquo;dehydration\u0026rsquo; may be blamed for the onset of physiological jaundice, and suggestions that the initiation of formula may avoid phototherapy need in the days after birth. These results are supported by other studies which showed infants with jaundice were twice as likely to have stopped breastfeeding at one month than infants without jaundice (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). Positive interactions and encouragement from healthcare professionals that breastfeeding despite jaundice is possible were one of the strongest predictors of successful breastfeeding. Only 8% of infants in our study did not receive any formula while an in-patient. While the use of biliblankets in our institution is in an effort to promote keeping the mother-infant dyad together and support breastfeeding, it seems use of biliblankets was a further risk factor in disruption of breast feeding. There was a statistically significant difference between groups in the number of infants receiving only formula at discharge (52% in the control group compared to 73% in the intervention group, p\u0026thinsp;=\u0026thinsp;0.04). There were non-significant differences seen in infants exclusively breastfeeding at discharge (13% in control group vs 4% in the intervention group, p\u0026thinsp;=\u0026thinsp;0.12) and infants receiving combination feeding at discharge (35% in the control group compared to 24% in the intervention group). While our study was not powered to detect differences in infant feeding, these numbers suggest that use of the biliblanket disrupted establishment of breastfeeding in an already vulnerable group, likely due to the cumbersome nature of caring for an infant on a biliblanket in the postnatal ward, and the fear of needing phototherapy and separation if the intervention failed.\u003c/p\u003e \u003cp\u003eOur study had several strengths, including the randomised nature and the pragmatic design, carried out on the postnatal wards of a busy tertiary maternity unit. We also had some limitations. We were underpowered in the control arm, which is likely attributable to Pragmatic trial design on postnatal ward. The level of the primary outcome seen in both groups was less than expected in our initial power calculation. This may be because the initiation of the study created a guideline for the treatment of infants who were nearing the treatment, where previously they may have been commenced on phototherapy. In line with our pragmatic design we continued to use the bilirubin nomogram which is in use in our institution rather than change to one of the more well-known graphs, such as the AAP or NICE guidelines. This may limit the generalisability of our results.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOur results suggest that the use of a \u0026lsquo;Biliblanket\u0026rsquo; to treat physiological jaundice approaching the treatment line in well term infants does not decrease need for overhead phototherapy with no difference in length of stay, and a potential for disruption of breastfeeding establishment, and therefore consideration should be given to discontinuing their use in this clinical scenario. Our results also suggests that phototherapy treatment should only be started when infants cross the phototherapy line, rather than when approaching, as the numbers ultimately needing treatment are low.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eLED \u0026ndash; light-emitting diode\u003c/p\u003e\n\u003cp\u003eAAP -\u0026nbsp;American Academy of Pediatrics\u003c/p\u003e\n\u003cp\u003eNICE -\u0026nbsp;National Institute for Health and Care Excellence\u003c/p\u003e\n\u003cp\u003eG6PD -\u0026nbsp;6-phosphate dehydrogenase deficiency\u003c/p\u003e\n\u003cp\u003eRCT - Randomised control trial\u003c/p\u003e\n\u003cp\u003eDCT - Direct Coombs test\u003c/p\u003e\n\u003cp\u003eIV -\u0026nbsp;intravenous\u003c/p\u003e\n\u003cp\u003eSD -\u0026nbsp;Standard Deviation\u003c/p\u003e\n\u003cp\u003eIQR -\u0026nbsp;Interquartile range\u003cstrong\u003e\u003c/strong\u003e\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eRole of funding:\u0026nbsp;\u003c/strong\u003eNo funding support was received for this project.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest statement:\u0026nbsp;\u003c/strong\u003eThe authors have no conflicts of interest to disclose related to this project.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement:\u0026nbsp;\u003c/strong\u003eData from the below study will be available from the authors on reasonable request\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAB, RM, JM and JS conceived and designed the study. AB and RM recruited participants and collected data. AB and JM performed the data analysis. AB drafted the initial manuscript. All authors critically revised the manuscript for important intellectual content and reviewed and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval:\u0026nbsp;\u003c/strong\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of The Coombe Hospital, (REC 21-2020) in June 2020. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate:\u0026nbsp;\u003c/strong\u003eWritten informed consent was obtained from the parents/guardians of all participants. \u0026nbsp;\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKeren R, Luan X, Friedman S, Saddlemire S, Cnaan A, Bhutani VK (2008) A comparison of alternative risk-assessment strategies for predicting significant neonatal hyperbilirubinemia in term and near-term infants. Pediatrics 121(1):e170\u0026ndash;e179\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaisels MJ, McDonagh AF (2008) Phototherapy for neonatal jaundice. N Engl J Med 358(9):920\u0026ndash;928\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eManagement of hyperbilirubinemia (2004) in the newborn infant 35 or more weeks of gestation. Pediatrics 114(1):297\u0026ndash;316\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHorn AR, Kirsten GF, Kroon SM, Henning PA, M\u0026ouml;ller G, Pieper C et al (2006) Phototherapy and exchange transfusion for neonatal hyperbilirubinaemia: neonatal academic hospitals' consensus guidelines for South African hospitals and primary care facilities. S Afr Med J 96(9):819\u0026ndash;824\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQattea I, Farghaly MAA, Elgendy M, Mohamed MA, Aly H (2022) Neonatal hyperbilirubinemia and bilirubin neurotoxicity in hospitalized neonates: analysis of the US Database. Pediatr Res 91(7):1662\u0026ndash;1668\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVidavalur R, Devapatla S (2022) Trends in hospitalizations of newborns with hyperbilirubinemia and kernicterus in United States: an epidemiological study. J Matern Fetal Neonatal Med 35(25):7701\u0026ndash;7706\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSun Y, Petersen JP, Wu C, Dreier JW, Maimburg RD, Henriksen TB et al (2023) Neonatal Phototherapy and Clinical Characteristics: The Danish National Patient Registry 2000\u0026ndash;2016. Clin Epidemiol 15:123\u0026ndash;136\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtkinson LR, Escobar GJ, Takayama JI, Newman TB (2003) Phototherapy use in jaundiced newborns in a large managed care organization: do clinicians adhere to the guideline? Pediatrics 111(5 Pt 1):e555\u0026ndash;e561\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSarathy L, Chou JH, Romano-Clarke G, Darci KA, Lerou PH (2024) Bilirubin Measurement and Phototherapy Use After the AAP 2022 Newborn Hyperbilirubinemia Guideline. Pediatrics. ;153(4)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBhutani VK, Zipursky A, Blencowe H, Khanna R, Sgro M, Ebbesen F et al (2013) Neonatal hyperbilirubinemia and Rhesus disease of the newborn: incidence and impairment estimates for 2010 at regional and global levels. Pediatr Res 74(1Suppl 1):86\u0026ndash;100\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlk\u0026eacute;n J, H\u0026aring;kansson S, Ek\u0026eacute;us C, Gustafson P, Norman M (2019) Rates of Extreme Neonatal Hyperbilirubinemia and Kernicterus in Children and Adherence to National Guidelines for Screening, Diagnosis, and Treatment in Sweden. JAMA Netw Open 2(3):e190858\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDonneborg ML, Hansen BM, Vandborg PK, Rodrigo-Domingo M, Ebbesen F (2020) Extreme neonatal hyperbilirubinemia and kernicterus spectrum disorder in Denmark during the years 2000\u0026ndash;2015. J Perinatol 40(2):194\u0026ndash;202\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSgro M, Campbell DM, Kandasamy S, Shah V (2012) Incidence of chronic bilirubin encephalopathy in Canada, 2007\u0026ndash;2008. Pediatrics 130(4):e886\u0026ndash;e890\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWu YW, Kuzniewicz MW, Wickremasinghe AC, Walsh EM, Wi S, McCulloch CE et al (2015) Risk for cerebral palsy in infants with total serum bilirubin levels at or above the exchange transfusion threshold: a population-based study. JAMA Pediatr 169(3):239\u0026ndash;246\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBurke BL, Robbins JM, Bird TM, Hobbs CA, Nesmith C, Tilford JM (2009) Trends in hospitalizations for neonatal jaundice and kernicterus in the United States, 1988\u0026ndash;2005. Pediatrics 123(2):524\u0026ndash;532\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBhutani VK, Johnson L (2009) Kernicterus in the 21st century: frequently asked questions. J Perinatol 29(Suppl 1):S20\u0026ndash;S24\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLauer BJ, Spector ND (2011) Hyperbilirubinemia in the newborn. Pediatr Rev 32(8):341\u0026ndash;349\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmos RC, Jacob H, Leith W (2017) Jaundice in newborn babies under 28 days: NICE guideline 2016 (CG98). Archives of disease in childhood -. Educ Pract Ed 102(4):207\u0026ndash;209\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKemper AR, Newman TB, Slaughter JL, Maisels MJ, Watchko JF, Downs SM et al (2022) Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics. ;150(3)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGamaleldin R, Iskander I, Seoud I, Aboraya H, Aravkin A, Sampson PD et al (2011) Risk factors for neurotoxicity in newborns with severe neonatal hyperbilirubinemia. Pediatrics 128(4):e925\u0026ndash;e931\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMuchowski KE (2014) Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician 89(11):873\u0026ndash;878\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMills JF, Tudehope D (2001) Fibreoptic phototherapy for neonatal jaundice. Cochrane Database Syst Rev 2001(1):Cd002060\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGale R, Dranitzki Z, Dollberg S, Stevenson DK (1990) A randomized, controlled application of the Wallaby phototherapy system compared with standard phototherapy. J Perinatol 10(3):239\u0026ndash;242\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchuman AJ, Karush G (1992) Fiberoptic vs conventional home phototherapy for neonatal hyperbilirubinemia. Clin Pediatr (Phila) 31(6):345\u0026ndash;352\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWoodall D, Karas JG (1992) A new light on jaundice. A pilot study. Clin Pediatr (Phila) 31(6):353\u0026ndash;356\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRosenfeld W, Twist P, Concepcion L (1990) A new device for phototherapy treatment of jaundiced infants. J Perinatol 10(3):243\u0026ndash;248\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOrringer K, Kileny S, Salada K, Sahloul E, Gebremariam A, Skoczylas M et al (2023) Biliblanket Utilization for Outpatient Treatment of Newborn Jaundice. Clin Pediatr (Phila) 62(7):725\u0026ndash;732\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaimburg RD, Olsen J, Sun Y (2016) Neonatal hyperbilirubinemia and the risk of febrile seizures and childhood epilepsy. Epilepsy Res 124:67\u0026ndash;72\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWickremasinghe AC, Kuzniewicz MW, Grimes BA, McCulloch CE, Newman TB (2016) Neonatal Phototherapy and Infantile Cancer. Pediatrics. ;137(6)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNewman TB, Wickremasinghe AC, Walsh EM, Grimes BA, McCulloch CE, Kuzniewicz MW (2016) Retrospective Cohort Study of Phototherapy and Childhood Cancer in Northern California. Pediatrics. ;137(6)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAuger N, Laverdi\u0026egrave;re C, Ayoub A, Lo E, Luu TM (2019) Neonatal phototherapy and future risk of childhood cancer. Int J Cancer 145(8):2061\u0026ndash;2069\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHealth Service Executive I Breastfeeding in a Healthy Ireland \u0026ndash; Health Service Executive Action Plan 2016\u0026ndash;2021* Implementation progress report Ireland 2024 [\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHealth Service Executive I Perinatal Statistics Report 2021 Ireland 2021 [\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWillis SK, Hannon PR, Scrimshaw SC (2002) The impact of the maternal experience with a jaundiced newborn on the breastfeeding relationship. J Fam Pract 51(5):465\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKemper K, Forsyth B, McCarthy P (1989) Jaundice, terminating breast-feeding, and the vulnerable child. Pediatrics 84(5):773\u0026ndash;778\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Table 1 and 2, 4","content":"\u003cp\u003eTable 1 and 2, 4 are available in the Supplementary Files section.\u003c/p\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":"Physiological jaundice, phototherapy, biliblanket, breastfeeding","lastPublishedDoi":"10.21203/rs.3.rs-8682096/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8682096/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose: \u003c/strong\u003eTo evaluate if biliblankets prevents the need for overhead phototherapy in neonates with physiological jaundice approaching the treatment line.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSingle-centre randomised trial carried out in a tertiary maternity unit. Infants ≥35 weeks gestation and \u0026gt;24 hours of age with suspected physiological jaundice were eligible if serum bilirubin level was within 35µmol/l of the treatment line. Infants admitted to the neonatal unit or with a positive pre-randomisation direct Coombs test were excluded. Infants were randomised to intervention arm (treatment with Biliblanket) or control arm (routine care). Primary outcome was need for overhead phototherapy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNinety-seven infants were included in an intention-to-treat analysis, 51 in intervention arm and 46 in control arm with no baseline imbalances. Sixteen percent in the intervention group and 15% in the control group required overhead phototherapy (p\u0026gt;0.99) and no difference in length of stay (p=0.6) was observed. More infants in the intervention arm were discharged receiving formula feeds exclusively (p=0.04) despite no difference in feeding intentions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUse of a biliblanket for physiological jaundice approaching the treatment line in well term infants does not decrease need for overhead phototherapy with no difference in length of stay, but a potential for disruption of breastfeeding establishment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial was retrospectively registered (ISRCTN29045982 - https://www.isrctn.com/) on 08/01/2022.\u003c/p\u003e","manuscriptTitle":"Influence of Biliblanket Treatment on Admission for Overhead Phototherapy in Term Infants Approaching the Treatment Line - A Randomised Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-03 16:12:06","doi":"10.21203/rs.3.rs-8682096/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":"dbaac5b6-b66e-48ab-a9a3-fb6b80e87cf9","owner":[],"postedDate":"February 3rd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-07T09:25:06+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-03 16:12:06","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8682096","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8682096","identity":"rs-8682096","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}