Impact of Phototherapy Blanket Treatment on Need for Overhead Phototherapy in Term Infants—A Randomised Controlled Trial (The Babies in Blankets Trial— <scp>BiB</scp> Trial)

AIM: To evaluate whether phototherapy blankets prevent the use of overhead phototherapy in neonates with total serum bilirubin level (TSB) approaching the treatment thresholds. METHODS: A single-centre randomised trial was performed in a tertiary maternity unit. Infants ≥ 35 weeks' gestation and > 24 h of age with suspected hyperbilirubinaemia were eligible if TSB levels were within 35 μmol/L (2.0 mg/dL) of treatment thresholds. Infants admitted to the neonatal unit or with a positive pre-randomisation direct Coombs test were excluded. Infants were randomised to the intervention (phototherapy blanket) arm or control (routine care) arm. Primary outcome was need for overhead phototherapy. RESULTS: Ninety-seven infants were included in the intention-to-treat analysis, 51 in the intervention and 46 in the control arm with no differences in baseline characteristics. Sixteen percent of the intervention group and 15% of 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). CONCLUSION: Use of phototherapy blankets in clinically well term infants with TSB levels below treatment thresholds does not decrease subsequent need for overhead phototherapy, has no effect on length of hospital stay, and may impact breastfeeding. TRIAL REGISTRATION: The trial was retrospectively registered (ISRCTN29045982-https://www.isrctn.com/) on 08/01/2022.