Gemfibrozil in Late Preterm and Term Neonates with Moderate Jaundice: A Randomized Controlled Trial.

ABSTRACT

Objective: To determine, if oral Gemfibrozil is effective in decreasing the duration of phototherapy by at least 24 hours in neonates >34 weeks gestation with nonhemolytic jaundice, as compared to placebo. Design: Double blind placebo controlled randomized controlled trial. Setting: Tertiary care neonatal unit in north India. Subjects: Ninety seven neonates >34 weeks gestation with non-hemolytic jaundice within first 7 days of life requiring phototherapy. Intervention Two doses of Gemfibrozil (60 mg/kg/dose) or placebo, 12 hours apart. Babies were treated with single surface special blue light phototherapy. Serum total bilirubin (STB) was measured 8 hourly. Phototherapy was stopped if two consecutive STB values were below phototherapy zone. Primary outcome measure: Duration of phototherapy. Results: The median (IQR) duration of phototherapy was 40 (30, 60) hours in Gemfibrozil and 36 (19, 55) hours in the placebo group (P=0.13). The peak STB levels were 16.8 ± 2.7 mg/dL and 16.3 ± 2.3 mg/dL in Gemfibrozil and placebo groups, respectively. No side effect of the drug or placebo was noticed. Conclusion: Two doses of gemfibrozil (60mg/kg/dose) given 12 hours apart were not able to reduce the duration of phototherapy, or peak bilirubin level in babies > 34 weeks gestation with non-hemolytic jaundice in the first week of life. Gemfibrozil was not associated with any side effects.