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.
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.
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.
Parallel
Fenofibrate + Phototherapy
DrugParticipants 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
DrugParticipants 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.
Change in total serum bilirubin (TSB)
Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups).
Duration of phototherapy
Duration of phototherapy given to neonates
Duration of Hospital Stay
Date of admission of neonate till its discharge date will be calculated as the hospital stay of neonate
Safety profile (adverse effects) including: Skin rash, Dehydration, Gastrointestinal symptoms, Hepatotoxicity, Renal impairment, Hypoglycemia, Sedation
Assessment of the safety of fenofibrate and phenobarbitone by monitoring the incidence of treatment-related adverse events, including skin rash, dehydration, gastrointestinal symptoms, hepatotoxicity, renal impairment, hypoglycemia, and sedation during the study period.
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Rubab Fatima
Lead sponsor
Sheikh Zayed Medical College
Sponsor institution
Sheikh Zayed Medical College
Collaborator
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