Non-invasive detection of bilirubin concentrations during the first week of life in a low-resource setting along the Thailand-Myanmar border

Background: Neonatal hyperbilirubinaemia (NH) is a common problem worldwide and causes morbidity and mortality especially in low-resource settings. Methods: A study was carried out at Shoklo Malaria Research Unit clinics along the Thailand-Myanmar border to evaluate a non-invasive test for diagnosis of NH in a low-resource setting. Performance of transcutaneous bilirubinometer Draäger Jaundice Meter JM-105 was assessed against routine capillary serum bilirubin testing before phototherapy during neonatal care in the first week of life. Results were analysed by direct agreement and by various bilirubin thresholds used in clinical practice. Total serum bilirubin was also measured in cord blood at birth and tested for prediction of hyperbilirubinaemia requiring phototherapy in the first week of life. Results: Between April 2020 and May 2023, 742 neonates born at SMRU facilities were included in the study. A total of 695 neonates provided 1 to 9 capillary blood samples for analysis of serum bilirubin (total 1244 tests) during the first week of life and performance of the transcutaneous bilirubinometer was assessed in 307 neonates who provided 687 paired transcutaneous-capillary blood tests. Bilirubin levels were also measured in 738 cord blood samples. Adjusted values of the transcutaneous bilirubinometer showed excellent agreement with capillary serum bilirubin concentration (intraclass correlation coefficient=0.923) and high sensitivity (>98%) at all clinical thresholds analysed across three years of sampling and multiple users. Concentrations of bilirubin detected in cord blood were not useful in identifying neonates at risk of hyperbilirubinaemia requiring treatment. Conclusions: The transcutaneous bilirubinometer is a reliable tool to screen neonates and identify those needing confirmatory blood testing. Bilirubin concentrations in cord blood are not predictive of hyperbilirubinemia in neonates. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was supported in part by a grant to GB by the Wellcome Trust Institutional Translational Partnership Awards: Thailand Major Overseas Programme (WT-iTP-2019/004). MEG is supported by the Tropical Network Fund of the University of Oxford. SMRU is supported by the Wellcome Trust (grant 220211). For the purpose of Open Access, the authors have applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study involves human participants and was approved by the Oxford Tropical Research Ethics Committee, UK (OxTREC 532-19), the Mahidol University Faculty of Tropical Medicine Ethics Committee, Thailand (TMEC 19-048, MUTM 2019-080-02) and the Tak Province Border Community Ethics Advisory Board (TCAB201904) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes De-identified participant data are available from the Mahidol Oxford Tropical Medicine Data Access Committee upon request from this link: https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/datasharing.