NCT04418180

Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: —

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.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DRUG	Fenofibrate	Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
DRUG	Placebo	oral distilled water

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-12
• First posted: 2020-06-05
• Last updated: 2020-06-05