Phenobarbitone in Rh hemolytic disease of the newborn: a randomized double-blinded placebo-controlled trial

J Trop Pediatr. 2013 Oct;59(5):380-6. doi: 10.1093/tropej/fmt032. Epub 2013 Jun 8.


Objective: To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn.

Study design: In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy.

Results: Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04).

Conclusions: PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.

Keywords: Rh hemolytic disease of the newborn (Rh-HDN); phenobarbitone; phototherapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Bilirubin / blood*
  • Double-Blind Method
  • Drug Administration Schedule
  • Erythroblastosis, Fetal / drug therapy*
  • Female
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Male
  • Phenobarbital / administration & dosage*
  • Phototherapy / methods
  • Treatment Outcome


  • Bilirubin
  • Phenobarbital