Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Khafaga, Khaled Abouelenin; Alsaid, Lofty Mohamed; Salama, Raafat Hassan; Abougabal, Maged Taher

doi:10.21608/ejhm.2022.258459

Fenofibrate As an Adjuvant to Phototherapy in Term Neonates with Hyperbilirubinemia; A Randomized Controlled Clinical Trial

Document Type : Original Article

Authors

10.21608/ejhm.2022.258459

Abstract

Background: Neonatal jaundice results from accumulation of bilirubin as fetal hemoglobin is metabolized by the immature liver. It may be physiological or pathological. Although most infants recover without major morbidity, yet some might develop sever hyperbilirubinemia and acute bilirubin encephalopathy as result of high levels of serum bilirubin. Fenofibrate is a member of the fibrates group. It is a safe and inexpensive orally administered fibric acid derivative conventionally used to treat dyslipidemia. In contrast to clofibrate, studies investigating value of fenofibrate in treatment of the conditions are scarce.The aim was to assess Fenofibrate as an adjuvant to phototherapy in Term Neonates with Hyperbilirubinemia; a prospective randomized controlled trial.
Patients and Methods: The study recruited 74 patients randomly divided into 2 equal groups. Patients were assigned to receive either phototherapy with single oral dose of fenofibrate suspension (10 mg/kg) on day 1 of phototherapy (Group 1), or phototherapy alone (Group 2).
Results: The 2 studied groups were comparable regarding the basic clinical and laboratory data. The whole series comprised 45 (60.8%) males and 29 (39.2%) females. Comparison between total serum bilirubin levels during treatment and on discharge levels showed significant improvement of bilirubin levels in the two studied groups (P-value 0.0001). Comparison between bilirubin levels in the 2 studied groups revealed significantly lower bilirubin levels in fenofibrate treated group when compared with the control group starting at 36 hours after admission till discharge. Conclusion: Fenofibrate as an adjuvant to phototherapy in neonates with hyperbilirubinemia is associated with significant reduction of serum bilirubin levels.

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