Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Fenofibrate as an Adjuvant to Phototherapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants: A Randomized Control Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04418180

Enrollment

Unknown

Registered

2020-06-05

Start date

2016-06-01

Completion date

Unknown

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

Keywords

Fenofibrate, Neonatal hyperbilirubinemia, Phototherapy

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.

Interventions

DRUGFenofibrate

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

DRUGPlacebo

oral distilled water

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Total serum bilirubin	24 hours of treatment	measure level of serum total bilirubin (mg/dl)

Secondary

Measure	Time frame	Description
length of hospital stay	expected 3 days of treatment	Duration of hospital admission (days)
duration of photo therapy	expected 48 hours of treatment	duration of photo therapy (hours)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026