Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age24-14
SponsorRubab Fatima

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

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Rubab Fatima

Lead sponsor

Sheikh Zayed Medical College

Sponsor institution

Sheikh Zayed Medical College

Collaborator