Validation of transcutaneous bilirubinometry during phototherapy for detection and monitoring of neonatal jaundice in a low-income setting

ABSTRACT

Background: Severe neonatal jaundice (SNJ) and the associated long-term health sequelae are a significant problem in low-income countries (LIC) where measurement of total serum bilirubin (TSB) is often unavailable. Transcutaneous bilirubinometry (TcB) provides the opportunity for non-invasive, point-of-care monitoring. Few studies have evaluated its agreement with TSB levels during phototherapy in LIC.

Aim: To determine agreement between TcB and TSB during phototherapy in a Haitian newborn population and to establish whether TcB can be safely used to guide treatment during phototherapy when TSB is unavailable.

Methods: A single-centre prospective study (February to May 2017) in Cap Haïtien, northern Haiti was undertaken. Newborns <7 days of age with clinically detected jaundice were eligible for inclusion. A TcB device (JM-103) was used to screen for newborn jaundice along with a parallel TSB. A strip of black tape was placed across the sternum during phototherapy and uncovered for subsequent TcB measurements. Decisions about phototherapy treatment were based upon UK National Institute of Clinical Excellence (NICE) threshold criteria. Paired TSB and TcB measurements were compared using Bland–Altman methods.

Results: The final analysis included 70 parallel TSB/TcB measurements from 35 infants within the first 5 days of life. Nineteen (54.3%) were male and 12 (34.3%) were <35 weeks. Thirty-two (91.4%) were receiving phototherapy. There was good agreement between TSB and TcB. Compared with TSB, TcB tended to over-estimate bilirubin (mean difference 11.1 µmol/L, 95% CI −10.2–32.5 µmol/L). However, at higher bilirubin levels (>250 µmol/L), TcB tended to under-estimate bilirubin compared with TSB and the difference increased.

Conclusion: In an LIC setting in which serum bilirubin testing is not commonly available, TcB demonstrates good agreement with TSB and can be safely used to guide jaundice treatment during phototherapy but can lead to over-treatment at lower bilirubin levels and are more inaccurate at higher levels. For TcB levels >250 µmol, confirmation with serum bilirubin should be performed, if available, to avoid under-estimation.

Abbreviations: LIC: low income countries; LMIC: low and middle income countries; TcB: transcutaneous bilirubinometry; TSB: transcutaneous serum biliubin

KEYWORDS:

• Jaundice
• transcutaneous bilirubinometry
• phototherapy
• low-income countries
• Haiti
• neonates
• newborn
• infants

Acknowledgments

We acknowledge the support of Drager for the charitable donation of a Drager JM-103 transcutaneous bilirubinometer. Drager had no involvement in the design and funding of the study or in the interpretation of the study results.This study is dedicated in loving memory to Noah Amos Damien Hill, 10 January to 29 March 2019.

Author Contributions

CB and VV identified the need for and conceptualised and designed the study. SJ and CM acquired the data. VV implemented the device into routine practice and LJ, PT were local leads. SJ wrote the first draft of the manuscript. PT and CH provided administrative and laboratory support enabling the study objectives to be met. CB conducted the statistical analysis and critical revision of the manuscript. All individuals will be involved in reporting and disseminating the findings in peer-reviewed journals and at conferences.

Consent

Parental informed verbal consent was obtained to reproduce the photograph which is Figure 1

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

Hope Health Action, a UK registered non-government organisation www.hopehealthaction.org provided funding. HHA has been providing maternal and infant health care with its local partner hospital Hospital Baptiste d’Haiti since its establishment in 2012.

Notes on contributors

S. M. Johnson

SM Johnson Paediatrician, V Vasu Consultant Neonatologist & Honorary Senior Lecturer, C Marseille Paediatrician, C Hill Founder and Chief Executive Officer of Hope Health Action, L Janvier Consultant Paediatrician and Head of Service, P Toussaint Consultant Paediatrician and Medical Director, C Battersby Honorary Consultant Neonatologist and Clinical Senior Lecturer.