Efficacy and Safety of Fenofibrate in Uncomplicated Hyperbilirubinemia in Newborn: A Randomized Trial, with a 6-month Follow-up

Abstract

Objective: To study the effect and safety of Fenofibrate in uncomplicated hyperbilirubinemia in newborn with 6-month follow-up. Materials and Methods: This is a randomized controlled clinical trial conducted in 60 normal term neonates admitted for uncomplicated hyperbilirubinemia in NICU at Sir T G Hospital, Bhavnagar from January 2012 to December 2012. The data included: age, sex, total serum bilirubin (TSB), weight and duration of phototherapy. All neonates enrolled in the study received phototherapy. They were divided in two groups of 30 each: control group A and group B receiving Fenofibrate (100 mg/kg single dose). There was statistically insignificant difference between the parameters of age, sex, weight and TSB between the two groups at hospitalization. Data was analyzed by using appropriate statistical methods. Results: Mean values for total serum bilirubin in Fenofibrate group B at 24 and 48 hours after admission were significantly lower than those for control group A (p<0.0001,  p=0.0001). There was no significant difference in fall of TSB between 24 and 48 hours. The mean duration of phototherapy in Fenofibrate group (44.8h: 24-72h) was significantly shorter than that in control group (55.2 h: 24‐96 h) (P=0.02). There were no side effects of the drug observed during the study and during 6 months follow up period. Conclusion: Fenofibrate as a single 100 mg/kg dose in healthy full term neonates, is effective and a safe drug (till six-month follow-up) for neonatal hyperbilirubinemia, that can decrease the time needed for phototherapy and hence hospitalization. Effect of a single dose seems to wane after 24 hours.