Related Experiment Video
Updated: Aug 20, 2025
Biochemical Measurement of Neonatal Hypoxia
Published on: August 24, 2011
Better assessment of neonatal jaundice at home (BEAT Jaundice @home): protocol for a prospective, multicentre
Lauren E H Westenberg1,2, Berthe A M van der Geest3,2, Hester F Lingsma4
1Division of Neonatology, Department of Paediatrics, Erasmus MC Sophia Children Hospital, University Medical Centre Rotterdam, Rotterdam, Zuid-Holland, The Netherlands l.westenberg@erasmusmc.nl.
Insights
This study compares transcutaneous bilirubin (TcB) screening with visual inspection for detecting neonatal hyperbilirubinaemia, aiming to improve diagnosis and reduce heel pricks. It also evaluates a smartphone app and a point-of-care device for bilirubin quantification.
Area of Science:
- Neonatal care
- Medical diagnostics
- Public health
Background:
- Severe neonatal hyperbilirubinaemia poses risks like acute bilirubin encephalopathy and kernicterus spectrum disorder.
- Current screening relies on visual inspection, which has limited reliability, followed by laboratory-based bilirubin quantification.
- Early diagnosis is crucial to prevent severe outcomes in newborns.
Purpose of the Study:
- To evaluate universal transcutaneous bilirubin (TcB) screening versus visual inspection for detecting hyperbilirubinaemia requiring treatment.
- To assess if TcB screening can reduce the number of heel pricks needed for bilirubin quantification.
- To evaluate a smartphone app (Picterus) and a point-of-care device (Bilistick) for bilirubin measurement.
Main Methods:
- A multicentre prospective cohort study in nine Dutch midwifery practices.
- Inclusion of neonates (≥35 weeks gestational age) at home between days 2-8 of life, with initial midwife visit before day 6.
- Use of TcB and Picterus app after visual inspection, with Bilistick used in parallel if laboratory-based bilirubin is indicated.
Main Results:
- The study aims to include 2310 neonates over a 2-year period.
- Coprimary endpoints are hyperbilirubinaemia necessitating treatment and the number of heel pricks for laboratory-based bilirubin quantification.
- A cost-effectiveness analysis will be performed using a decision tree model.
Conclusions:
- The study will provide insights into the effectiveness of TcB screening and novel devices for neonatal hyperbilirubinaemia management.
- Findings are expected to inform clinical practice and potentially improve early detection and reduce invasive procedures.
- Results will be published in peer-reviewed journals following ethical approval and informed consent.
Introduction:
Severe neonatal hyperbilirubinaemia can place a neonate at risk for acute bilirubin encephalopathy and kernicterus spectrum disorder. Early diagnosis is essential to prevent these deleterious sequelae. Currently, screening by visual inspection followed by laboratory-based bilirubin (LBB) quantification is used to identify hyperbilirubinaemia in neonates cared for at home in the Netherlands. However, the reliability of visual inspection is limited. We aim to evaluate the effectiveness of universal transcutaneous bilirubin (TcB) screening as compared with visual inspection to: (1) increase the detection of hyperbilirubinaemia necessitating treatment, and (2) reduce the need for heel pricks to quantify bilirubin levels. In parallel, we will evaluate a smartphone app (Picterus), and a point-of-care device for quantifying total bilirubin (Bilistick) as compared with LBB.
Methods And Analysis:
We will undertake a multicentre prospective cohort study in nine midwifery practices across the Netherlands. Neonates born at a gestational age of 35 weeks or more are eligible if they: (1) are at home at any time between days 2 and 8 of life; (2) have their first midwife visit prior to postnatal day 6 and (3) did not previously receive phototherapy. TcB and the Picterus app will be used after visual inspection. When LBB is deemed necessary based on visual inspection and/or TcB reading, Bilistick will be used in parallel. The coprimary endpoints of the study are: (1) hyperbilirubinaemia necessitating treatment; (2) the number of heel pricks performed to quantify LBB. We aim to include 2310 neonates in a 2-year period. Using a decision tree model, a cost-effectiveness analysis will be performed.
Ethics And Dissemination:
This study has been approved by the Medical Research Ethical Committee of the Erasmus MC Rotterdam, Netherlands (MEC-2020-0618). Parents will provide written informed consent. The results of this study will be published in peer-reviewed journals.
Trial Registration Number:
Dutch Trial Register (NL9545).
