Phenobarbitone for prevention of periventricular haemorrhage in very low birth-weight infants. A randomised double-blind trial.

A double-blind randomised trial was carried out in 60 infants with a birth-weight of less than 1500 g or a gestational age below 31 weeks. 30 infants received phenobarbitone (20 mg/kg) within 4 h of birth and 30 infants received a placebo. The two groups of infants were similar in birth-weight, gestational age, frequency of vaginal delivery, sex, Apgar scores, ventilator dependence before the injection, pneumothorax, hypercapnia, and acidosis. Cranial ultrasound scans were carried out daily for 14 days. 12 out of 30 phenobarbitone-treated infants and 11 out of 30 placebo-treated infants had PVH, with parenchymal haemorrhages in 2 of the placebo group. Plasma phenobarbitone was over 15 micrograms/ml in 28 out of 30 of the phenobarbitone-treated infants during the first 72 h. 7 out of 17 spontaneously breathing infants became ventilator-dependent within 12 h of the phenobarbitone injection, whereas only 1 of 18 spontaneously breathing placebo-treated infants became ventilator-dependent within 12 h of injection. Although the possibility of protection against parenchymal haemorrhages may justify further investigation, there is no justification for administration of 20 mg/kg of phenobarbitone to all infants below 1500 g.

RCT Entities:   Population Interventions Outcomes