About this trial
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.
Eligibility criteria
Qualifiers
Term neonates aged 24 hours to 14 days with gestational age 37-42 weeks.
Birth weight ≥2500 g.
Physiological, non-haemolytic indirect hyperbilirubinemia with total serum bilirubin 15-20 mg/dL, requiring phototherapy according to age-specific guidelines.
Written informed consent from parents or legal guardian.
Disqualifiers
Preterm or low-birth-weight neonates.
Jaundice appearing within the first 24 hours of life.
ABO or Rh incompatibility, positive direct Coombs test, or any evidence of haemolysis.
Neonates with sepsis, birth asphyxia, shock, congenital anomalies, cholestasis, liver or renal disease.
Trial design
Treatments tested in this trial
- Fenofibrate + Phototherapy
- Phenobarbitone + Phototherapy
Treatment groups
Locations
Sponsors and collaborators
Rubab Fatima
Lead sponsor
Sheikh Zayed Medical College
Sponsor institution
Sheikh Zayed Medical College
Collaborator