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Effect of clofibrate in jaundiced full-term infants:a randomized clinical trial
Yadollah Zahedpasha1, Mousa Ahmadpour-Kacho, Mahmood Hajiahmadi
1Department of Pediatrics and Neonatology, Babol University of Medical Sciences, Babol, Iran. yzpasha@yahoo.com
Insights
Clofibrate significantly reduces total serum bilirubin (TSB) in jaundiced newborns, leading to shorter hospital stays. This study found clofibrate to be a safe and effective treatment for nonhemolytic jaundice in full-term infants.
Area of Science:
- Neonatal Medicine
- Pediatric Pharmacology
- Bilirubin Metabolism
Background:
- Neonatal hyperbilirubinemia is a prevalent condition that can lead to kernicterus if untreated.
- Early intervention is crucial for managing severe forms of neonatal jaundice.
Purpose of the Study:
- To evaluate the therapeutic efficacy of clofibrate in full-term neonates presenting with nonhemolytic jaundice.
- To assess the impact of clofibrate on bilirubin levels and hospitalization duration.
Main Methods:
- A randomized clinical trial involving 60 full-term jaundiced neonates.
- Two groups were formed: clofibrate treatment (100 mg/kg oral dose) and a control group receiving a placebo, both under phototherapy.
- Serum total and direct bilirubin levels were monitored at multiple time points (0, 16, 24, 48, 74 hours).
Main Results:
- The clofibrate group showed a statistically significant faster decline in total serum bilirubin (TSB) levels compared to the control group after 48 hours (P = 0.047).
- A higher proportion of neonates in the clofibrate group (83%) were discharged with TSB <10 mg/dL within 72 hours compared to the control group (53%) (P = 0.026).
- No adverse side effects were observed in the clofibrate-treated infants during hospitalization or follow-up.
Conclusions:
- Clofibrate administration accelerates the reduction of TSB in full-term neonates with nonhemolytic jaundice.
- The use of clofibrate leads to a shorter duration of hospitalization for jaundiced newborns.
- Clofibrate demonstrates a favorable safety profile with no observed side effects in this study population.
Background:
Hyperbilirubinemia is a common problem in newborn infants. It can progress to kernicterus in severe forms, unless an intervention is initiated. The objective of this study was to determine the therapeutic effect of clofibrate in full-term neonates with nonhemolytic jaundice.
Methods:
A randomized clinical trial was performed on two groups of full-term jaundiced neonates: the clofibrate-treated group (n = 30) and the control group (n = 30). Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate while the neonates in the control group received distilled water (same color and volume); both groups received phototherapy. Serum total and direct bilirubin levels were measured at the beginning, 16, 24, 48, and 74 hours, after the start of the trial.
Results:
The mean+/-SD total serum bilirubin level of the control and clofibrate groups at enrollment was 17.5+/-2.3 and 18.2+/-1.9 mg/dL, respectively (P = 0.199). The mean+/-SD total serum bilirubin in the control and clofibrate groups after 48 hours was 11.4+/-2.4 and 10.1+/-2.4 mg/dL, respectively (P = 0.047). After 72 hours of intervention, 25 (83%) neonates of the clofibrate group and 16 (53%) of the control group were discharged with a total serum bilirubin of <10 mg/dL (P = 0.026). No side-effect was observed on serial examination during hospitalization, and on the first and seventh day after discharge.
Conclusion:
Clofibrate results in a faster decline in TSB, shorter duration of hospitalization and had no side effects in jaundiced full-term neonates.
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