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.
Abstract

Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Hepatic Encephalopathy01:29

Hepatic Encephalopathy

DefinitionHepatic encephalopathy is a reversible neurologic syndrome that results from advanced liver dysfunction or portosystemic shunting. It leads to disturbances in cognition, behavior, and motor function due to the brain’s exposure to gut-derived toxins that the liver fails to detoxify.EtiologyThis condition develops either in the setting of acute fulminant hepatitis or progressively during chronic liver disease, such as cirrhosis and portal hypertension. Portosystemic shunting—including...
Jaundice01:25

Jaundice

Jaundice, or icterus, is the yellow discoloration of the skin, sclerae, and mucous membranes. It happens when plasma bilirubin levels rise above 2.5-3 mg/dL, leading to bilirubin deposition in tissue.Bilirubin is a byproduct of hemoglobin degradation. In macrophages, hemoglobin breaks down into globin and heme. Globin is converted into amino acids, while heme is turned into biliverdin by heme oxygenase, which is then reduced to unconjugated bilirubin by biliverdin reductase.Unconjugated...