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Study aim
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To determine the effect of oral fenofibrate on term neonatal hyperbilirubinemia admitted to hospital
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Design
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A single-center randomized controlled trial, parallel groups including 86 neonates enrolled between July 2019 and July 2020 with blinded outcome assessment, randomization by the Random Allocation software
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Settings and conduct
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Neonates with hyperbilirubinemia admitted to the Pediatric Hospital of Bandar Abbas from 2019 to 2020 with regard to the inclusion and exclusion criteria, entered the study after obtaining informed consent from their parents. The intervention group received 10 mg/dl fenofibrate dissolved in 5 ml of distilled water. Then, both groups received phototherapy. Total bilirubin was measured on admission (before treatment) and subsequently every 24 hours until discharge (bilirubin <10 mg/dl). All neonates were visited as outpatients within the first week post-discharge for potential drug complications. To avoid any confounding effect, phototherapy was performed using the same device, with the same lights, half-lives, color, and wavelength. Bilirubin was measured using the caffeine method via spectrophotometry. Results and outcomes were evaluated by the investigator blinded to the groupings.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: gestational age >=37 weeks, weight >=2500 g, 72 hours>= age <=7 days, 15>= total bilirubin <=20 mg/dl
Exclusion criteria: hemolytic diseases (ABO or Rh incompatibility), direct hyperbilirubinemia >2 mg/dl, G6PD deficiency, any specific disease including infections, systemic diseases, cephalohematoma, bowel obstruction, asphyxia, congenital anomalies, or chromosomal abnormalities, phenobarbital intake before or after birth
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Intervention groups
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Intervention group: phototherapy + 10 mg/kg fenofibrate dissolved in 5 ml of distilled water
Control group: phototherapy
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Main outcome variables
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Hospital length of stay