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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Sponsor: Rubab Fatima
Summary
This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia. The study aims to compare their effectiveness in reducing total serum bilirubin. Secondary outcomes include duration of phototherapy, length of hospital stay, and treatment-related adverse effects.
Key Details
Gender
All
Age Range
24 Hours - 14 Days
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-10
Completion Date
2027-10
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
Fenofibrate + Phototherapy
Participants randomized to the experimental group will receive a single oral dose of fenofibrate in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.
Phenobarbitone + Phototherapy
Participants randomized to the active comparator group will receive oral phenobarbitone in addition to standard phototherapy. Phototherapy will be administered according to the hospital's neonatal jaundice management protocol. Clinical assessment and serial total serum bilirubin measurements will be performed as per the study protocol until the infant meets the criteria for discontinuation of phototherapy and discharge.