Exploring the role of peroxisome proliferator- activated receptor agonists (fenofibrate) in neonatal jaundice prevention

Abstract Background Neonatal jaundice is one of the most prevalent illnesses in neonates, requiring care and treatment. Fenofibrate is a lipid-lowering drug that enhances the conjugation and excretion of bilirubin. Previous studies have suggested the usefulness of fenofibrate for the treatment of indirect hyperbilirubinemia in neonates. Objective To evaluate the role of fenofibrate in neonates with neonatal jaundice near the level of phototherapy. Patients and Methods seventy- five full-term infants with neonatal jaundice near the level of phototherapy were randomly divided into three groups: single-dose group: 25 neonates received a single oral dose of 10 mg/kg of non-micronized fenofibrate and an oral dose of an equivalent amount of distilled water as a placebo. Double-dose group: 25 neonates received two oral doses of 10 mg/kg non-micronized fenofibrate. The control group included 25 neonates who received two oral doses of an equivalent amount of distilled water as a placebo. Results The double-dose group had the highest significant drop in transcutaneous bilirubin (TCB) starting from 12 to 48 h after drug intake and the highest drop in total serum bilirubin (TSB) starting from 12 h to the 5th day in comparison to the single-dose group and the controls. The single-dose and double-dose groups had a significantly lower incidence of the need for admission and phototherapy than the control group ( P  = 0.009). The double-dose group had a significantly higher incidence of drug side effects than the single-dose group ( P  < 0.001), mainly in the form of abdominal distension (P = 0.008); however, only minor treatment was required. Conclusion Fenofibrate can significantly decrease bilirubin levels in full-term neonates with neonatal jaundice near the level of phototherapy, with no need for admission and phototherapy management. The drug was well-tolerated and safe. Double-dose treatment with fenofibrate significantly lowered TSB with no significant increase in side effects when compared to the single-dose group.