Clofibrate for non-hemolytic icterus in term newborns: Randomized-controlled trial, Iran

Abstract

Objectives: To compare the effects of a single dose of clofibrate on the serum bilirubin level in full-term non-hemolytic icteric neonates when it is administered in addition to phototherapy, and to evaluate its possible side effects. Methods: In a randomized-controlled clinical trial in 2016, 90 term icteric neonates were divided into groups of 30. One group took a single dose of 50 mg/kg while another group took a single dose of 100 mg/kg of clofibrate. All neonates were under phototherapy and were compared to a control group who took a placebo. Serum bilirubin levels were measured at admission and then after 6, 12, 24, and 48 hours of treatment. Clofibrate's side effects were assessed by measuring hepatic enzymes (AST/ALT) and lipid profiles (TG/Chol) at admission and after 48 hours. Results: In neonates with jaundice who were under phototherapy, a single dose of 100 mg/kg of clofibrate decreased the level of serum bilirubin more rapidly compared to the control group (t (58) = -2.73, P = 0.043), or even the group who took a single dose of 50 mg/kg clofibrate (t (58) = -4.261, P = 0.000). A single dose of 50 mg/kg clofibrate did not decrease the serum bilirubin levels more rapidly compared to the control group. Compared to the control group, in the group who took a single dose of 50 mg/kg clofibrate, after 48 hours, a higher number of neonates showed an increase in serum triglyceride (30% versus 63%) and/or cholesterol levels (27% versus 57%). Conclusions: A single dose of 100 (not 50) mg/kg clofibrate better decreased the serum bilirubin.