70 - Impact of universal transcutaneous bilirubin screening on severe neonatal hyperbilirubinaemia incidence in primary care: a stepped-wedge cluster randomised controlled trial

Poster Number: 70
Publication Number: 70.406

Background: Severe neonatal hyperbilirubinaemia (SNH) may cause acute bilirubin encephalopathy and kernicterus spectrum disorder if not recognised and treated in time. In many settings, hyperbilirubinaemia screening is based on visual jaundice assessment and selective total serum bilirubin (TSB) quantification. However, visual assessment is known to be unreliable. Earlier detection via transcutaneous bilirubin (TcB) screening may facilitate earlier treatment and reduce the risk of SNH.

Objective: We evaluated whether daily TcB screening could reduce the incidence of SNH among (near) term neonates cared for in primary care.

Design/Methods: We undertook a factorial stepped-wedge cluster randomised controlled trial in seven primary care birth centres (PCBCs) in the Netherlands from July 2018 to December 2021. Neonates born after 35 weeks of gestation and admitted to a PCBC during the first week of life were eligible. As one of two interventions evaluated in parallel, daily TcB screening was compared to visual jaundice assessment, the current standard care. During the control phase, TSB was quantified to the discretion of the attending midwife based on visual assessment, and during the intervention phase if TcB was above or ≤50 µmol/L below the phototherapy threshold according to the national guideline. The primary outcome was SNH: TSB > ((phototherapy threshold + exchange transfusion threshold)/2).

Results: There were recruitment challenges, in part due to the COVID-19 pandemic, and despite prolongation of the trial, according to the stepped-wedge design, the trial ended when 2943 neonates were included (55% of the required sample size): 1312 in the control phase and 1631 in the intervention phase. The median number of TcB quantifications per neonate was 2 (IQR 2-3). TSB was quantified in 273 (20.8%) and 292 (17.8%) neonates in the control and the intervention phase, respectively. During the control phase 29/1312 (2.2%) neonates had SNH, during the intervention phase this was 42/1631 (2.6%). In the intention-to-treat analysis, daily TcB screening had no significant impact on the proportion of neonates having SNH: OR 1.5 (95%CI 0.8-2.6). No exchange transfusions were performed in either arm.

Conclusion(s): In this cluster RCT in primary care, universal TcB screening did not significantly reduce the proportion of (near) term neonates experiencing SNH. Although sample size requirements were not met, this is by far the largest RCT exploring universal TcB screening, with no clear signal of benefit. Secondary analyses will explore whether selective TcB screening may be a better alternative.