Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Background: Despite widespread phototherapy usage, many newborn infants remain in need of
other lines of invasive therapy such as intravenous immunoglobulins and exchange
transfusions.
Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for
treatment of pathological jaundice in full term infants.
Design/Methods: We conducted a double blinded randomized control study on 180 full-term
infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura
University Children's Hospital. They were randomly assigned to receive either oral
fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total
serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were
total duration of treatment, need for exchange transfusions and intravenous immunoglobulin,
exclusive breast-feeding on discharge, and adverse effects of fenofibrate.