A randomized, triple-blind, placebo-controlled trial of prophylactic oral phenobarbital to reduce the need for phototherapy in G6PD-deficient neonates.

摘要: Decreased conjugation is probably more important than hemolysis for causing jaundice in G6PD-deficient neonates. The role of enzyme inducers, like phenobarbital, G6PD deficiency unclear. This randomized controlled trial was performed to evaluate Phenobarbital's reducing the need phototherapy among stratified, randomized, triple-blinded, placebo-controlled conducted a level III NICU. Consecutive babies with gestation ≥34 weeks and birth weight ≥1800 g were screened from cord blood. neonates, who otherwise healthy, enrolled. Rh isoimmunization, maternal Phenobarbital use lack parental consent exclusion criteria. Subjects randomly allocated receive 5 mg/kg day oral phenobarbital/ placebo first 3 days. They monitored daily total serum bilirubin (TSB) until declining TSB documented twice. primary outcome requirement secondary outcomes duration phototherapy, exchange transfusion, peak adverse effects. Sample size 56 could detect decline 40 5% 80% power error. Of 2370 screened, 63 G6PD-deficient. them, eligible phenobarbital (n=27) or (n=29). mean age administration dose 18.55±7.3 h. In total, 44% group 41% required (p=1.0). There no significant difference transfusion rates (18.5 vs 10%, p=0.46). No baby had reactions. Prophylactic does not decrease transfusions