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

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

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.

Neonatal hyperbilirubinemia is one of the most common conditions requiring medical attention during the neonatal period. Although phototherapy is the standard treatment for uncomplicated indirect hyperbilirubinemia, adjuvant pharmacological therapies may enhance bilirubin clearance and reduce the duration of phototherapy and hospital stay.

Fenofibrate induces hepatic enzymes involved in bilirubin conjugation and excretion, whereas phenobarbitone has traditionally been used to increase bilirubin metabolism through enzyme induction. The comparative effectiveness of these two agents as adjuncts to phototherapy has not been adequately evaluated.

This Phase IV, prospective, randomized, open-label, parallel-group clinical trial aims to compare the efficacy and safety of fenofibrate versus phenobarbitone as adjuncts to conventional phototherapy in neonates with indirect hyperbilirubinemia.

Eligible neonates will be randomly assigned in a 1:1 ratio to receive either fenofibrate plus phototherapy or phenobarbitone plus phototherapy. The primary outcome is the reduction in total serum bilirubin. Secondary outcomes include the duration of phototherapy, length of hospital stay, need for exchange transfusion (if applicable), and the occurrence of adverse events. Participants will be followed until resolution of hyperbilirubinemia and discharge according to the study protocol.

The results of this study are expected to provide evidence regarding the more effective adjunctive therapy for the management of neonatal indirect hyperbilirubinemia.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Neonates with electrolyte, acid-base, coagulation, or intrauterine infection-related disorders.
• Previous neonatal use of fenofibrate or phenobarbitone, or maternal phenobarbitone use during pregnancy.