The Effect of Oral Fenofibrate on Serum Bilirubin Level in Term Neonates with Hyperbilirubinemia: A Randomized Clinical Trail

Authors

1 Professor of pediatrics and neonatology, Non-Communicable Pediatric Diseases Research Center, Department of Pediatrics, Babol University of Medical Sciences, Babol, IR Iran.

2 Professor of Pediatrics and Neonatology, Non-Communicable Pediatric Diseases Research Center, Department of Pediatrics, Babol University of Medical Sciences, Babol, IR Iran.

3 Professor, Department of Pharmacology, Ganj Afrooze Avenue, Faculty of Medicine, Babol University of Medical Sciences, Babol, IR Iran.

4 Statistical analysis, Department of Social Medicine, Babol University of Medical Sciences, Babol, Iran.

5 Fellow of Neonatology, Amirkola Children’s Hospital, Department of Pediatrics, Babol University of medical Sciences, Babol, IR Iran.

Abstract

Background
Several agents have been used for the treatment of neonatal hyperbilirubinemia, but the effect of oral fenofibrate on serum bilirubin level was not evaluated so much. The aim of this study was to assess the effect of oral fenofibrate on a total serum bilirubin (TSB) in term neonates with hyperbilirubinemia.
Materials and Methods: This clinical trial was done on 80 term neonate with a TSB higher than 15 mg/dl in two equal groups of control and intervention. Both groups received conventional phototherapy with the same condition. The intervention group received a single dose of oral Fenofibrate (Sobhan- Darou Company, Iran) 10 mg/kg. The TSB was measured in both groups, at admission, second day, and third day and also at the time of discharge. The serum bilirubin level, the duration of phototherapy and need to exchange transfusion were compared in two groups.
Results: Results showed that of 80 neonates studied, the TSB at the second day of hospitalization in the intervention group was 13.29 ±1. 64 mg/dl and in control group 14.06±1.78 mg/dl (p=0.04), and at the third day in intervention group it was decreased to 9.99± 1.53 (p=0.04), and in control group  to 11.01±1.68 mg/dl, (p=0.006). The duration of phototherapy in the intervention group was 2.5±0.71 days and in control group 3.35±0.97 days (p=0.003).  
Conclusion
According to the result of this study administration of oral Fenofibrte in a term neonate with hyperbilirubinemia under the phototherapy lead to faster decline in serum bilirubin levels, shorten the duration of hospital stay and earlier discharge from hospital.

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