Role of Fenofibrate in Neonatal Jaundice

Prophylactic Role of Fenofibrate in Neonatal Jaundice

Fenofibrate appears to be an effective and safe drug for the treatment of neonatal hyperbilirubinemia. It has been proven that it decreases the duration of phototherapy and thus shortens the length of hospital stay.

This study was performed to study the prophylactic role of fenofibrate in prevention of neonatal jaundice.

Study Overview

• Status: Completed
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Drug: Fenofibrate; Other: placebo

Detailed Description

Neonatal jaundice is a common disease in neonates. Based on current statistics, 60% of term neonates and 80% of preterm neonates suffer from jaundice during the first week of birth The normal bilirubin level of the umbilical cord is 1-3 mg/dL, which increases to 5-6 mg/dL on the second to fourth days after birth and decreases to less than 2 mg/dL on the 5th to 7th days after birth .

Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted. In neonates, this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation.

Free bilirubin deposits in the skin and mucous membranes and produces jaundice. It may also deposit in the brain where it has been implicated in causing transient dysfunction and, occasionally, permanent neuronal damage.

Every year, a huge hospital cost is imposed on parents for the treatment of neonatal jaundice. Moreover, it leads to the mother-child separation and subsequent mental health problems. Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications . medication has also been used to prevent and treat neonatal jaundice Including IVIG, protoporphyrin, phenobarbital and fenofibrate.

Fibrates have been used for several years as a hypolipidemic drug in adults.They exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues . Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity. Its potency to induce bilirubin conjugation is very high. Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate. Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity, it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism. Fenofibrate is very similar to clofibrate in its action. However, it is simply more accessible and has more safety profile, therefore, it is much safer to be given to children than clofibrate. Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt
      • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• full-term (37 to 41 weeks),
• Appropriate for gestational age weight between 2500 to 3500 gm infants
• neonatal hyperbilirubinemia not reaching the level of phototherapy.

Exclusion Criteria:

• Newborns with congenital malformations.
• Conjugated hyperbilirubinemia.
• Newborns who need exchange transfusion and phototherapy.
• Newborns presenting with ABO or Rh incompatibility.
• G6PD deficiency.
• Newborns with skin abrasions or infections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fenofibrate single dose; full term neonates will receive a single oral dose of 10 mg/kg of non- micronized fenofibrate	Drug: Fenofibrate; full-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group; Other Names: lipid lowering drug
Experimental: fenofibrate double dose; full term neonates will receive two oral doses of 10 mg/kg of non - micronized fenofibrate.	Drug: Fenofibrate; full-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group; Other Names: lipid lowering drug
Placebo Comparator: placebo; full term neonates will receive equivalent amount of distilled water.	Other: placebo; ull-term (37 to 41 weeks), Appropriate for gestational age weight between 2500 to 3500 gm infants and with neonatal hyperbilirubinemia not reaching the level of phototherapy were randomised to receive the drug in different doses or in the control group; Other Names: control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in total serum bilirubin	Decline in total serum bilirubin values per unit of time after 12, 24, 36, 48 hours, 5 days from intervention.	up to 5 days
start of phototherapy	time at which phototherapy will be initiated from receiving the drug and till 5 days later	up to 5 days
start of exchange transfusion	time at which patient needed to perform exchange transfusion after receiving the drug till five days later	up to 5 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: prophylaxis; fenofibrate; neonatal jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: prophylactic fenofibrate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be provided when requested appropriately for reasonable reasons from the main investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No