Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

NCT04418180 | Completed

• 1 other identifier: MansouraU003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions. Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants. Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.

Conditions

Neonatal Jaundice

Keywords

Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy

Outcome Measures

Primary Outcomes (3)

• Total serum bilirubin

  measure level of serum total bilirubin (mg/dl)

  24 hours of treatment

• Total serum bilirubin

  measure level of serum total bilirubin (mg/dl)

  48 hours of treatment

• Total serum bilirubin

  measure level of serum total bilirubin (mg/dl)

  72 hours of treatment

Secondary Outcomes (2)

• length of hospital stay

  expected 3 days of treatment

• duration of photo therapy

  expected 48 hours of treatment

Study Arms (3)

GROUP1

ACTIVE COMPARATOR

group receiving single dose fenofibrate

Drug: Fenofibrate

GROUP2

ACTIVE COMPARATOR

group receiving double dose fenofibrate

Drug: Fenofibrate

GROUP3

PLACEBO COMPARATOR

photo therapy only

Drug: Placebo

Interventions

Fenofibrate DRUG

Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr

GROUP1; GROUP2

Placebo DRUG

oral distilled water

GROUP3

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines

You may not qualify if:

• Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (1)

• Awad MH, Amer S, Hafez M, Nour I, Shabaan A. "Fenofibrate as an adjuvant to phototherapy in pathological unconjugated hyperbilirubinemia in neonates: a randomized control trial.". J Perinatol. 2021 Apr;41(4):865-872. doi: 10.1038/s41372-020-00861-2. Epub 2020 Oct 17.

  PMID: 33070152 DERIVED

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2016
• Primary Completion: December 12, 2018
• Last Updated: June 5, 2020

Record last verified: 2020-06