"Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized

Mohammad Hosny Awad1, Sahar Amer2, Mona Hafez3

  • 1Department of pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt. mo7amed_hosny@hotmail.com.

Insights

Adding fenofibrate to phototherapy significantly reduces bilirubin levels in newborns with jaundice. This treatment shortens phototherapy duration and hospital stays, promoting exclusive breastfeeding without adverse effects.

Area of Science:

  • Neonatal Medicine
  • Pediatric Gastroenterology
  • Pharmacology

Background:

  • Pathological jaundice in newborns often requires invasive treatments beyond phototherapy.
  • Existing therapies like intravenous immunoglobulin and exchange transfusions carry significant risks.

Purpose of the Study:

  • To evaluate the efficacy and safety of fenofibrate as an adjunct to phototherapy for pathological jaundice in full-term infants.
  • To determine if fenofibrate can reduce the need for more invasive treatments.

Main Methods:

  • A double-blind, randomized controlled study involved 180 full-term infants with pathological unconjugated hyperbilirubinemia.
  • Infants received either oral fenofibrate (10 mg/kg/day for 1 or 2 days) or placebo, alongside phototherapy.
  • Primary outcome: total serum bilirubin levels at 12, 24, 36, 48, and 72 hours.

Main Results:

  • Fenofibrate groups showed a significant reduction in bilirubin levels at 36, 48, and 72 hours compared to the placebo group.
  • Fenofibrate administration led to a shorter duration of phototherapy and hospital stay.
  • Higher rates of exclusive breastfeeding on discharge were observed in fenofibrate-treated infants.

Conclusions:

  • Fenofibrate is well-tolerated as an adjuvant to phototherapy in term neonates with pathological jaundice.
  • It significantly reduces serum bilirubin levels, shortens treatment duration, and improves breastfeeding rates.
  • No significant adverse effects were noted with single or double dosage regimens.
Abstract

Related Concept Videos

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...
105
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...
133
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
127
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
159
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
100
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
101