Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418180
• Other study ID #: MansouraU003
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 12, 2018
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Drug:
• Fenofibrate
Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
• Placebo
oral distilled water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total serum bilirubin	measure level of serum total bilirubin (mg/dl)	24 hours of treatment
Primary	Total serum bilirubin	measure level of serum total bilirubin (mg/dl)	48 hours of treatment
Primary	Total serum bilirubin	measure level of serum total bilirubin (mg/dl)	72 hours of treatment
Secondary	length of hospital stay	Duration of hospital admission (days)	expected 3 days of treatment
Secondary	duration of photo therapy	duration of photo therapy (hours)	expected 48 hours of treatment