Role of Fenofibrate in Neonatal Jaundice

NCT06451900 | Completed Phase 4

• 1 other identifier: prophylactic fenofibrate
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Jaundice

Keywords

neonatal jaundice; prophylaxis; fenofibrate

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

fenofibrate single dose

EXPERIMENTAL

full term neonates will receive a single oral dose of 10 mg/kg of non- micronized fenofibrate

Drug: Fenofibrate

fenofibrate double dose

EXPERIMENTAL

full term neonates will receive two oral doses of 10 mg/kg of non - micronized fenofibrate.

Drug: Fenofibrate

placebo

PLACEBO COMPARATOR

full term neonates will receive equivalent amount of distilled water.

Other: placebo

Interventions

Fenofibrate DRUG

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

Also known as: lipid lowering drug

fenofibrate double dose; fenofibrate single dose

placebo OTHER

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

Also known as: control

placebo

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbassia, Egypt

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Fenofibrate; Hypolipidemic Agents

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Paediatrics, Ain Shams university

Model Details: full-term (37 to 41 weeks),Appropriate for gestational age weight between 2500 to 3500 gm infants with neonatal hyperbilirubinemia not reaching thel evel of phototherapy.The participants in our study will be divided in to three groups: Group A: full term neonates received a single oral dose of 10 mg/kg of non- micronized fenofibrate Group B: full term neonates received two oral doses of 10 mg/kg of non - micronized fenofibrate. Group C: full term neonates received equivalent amount of distilled water.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)