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Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

M

Mansoura University

Status

Completed

Conditions

Neonatal Jaundice

Treatments

Drug: Placebo
Drug: Fenofibrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04418180
MansouraU003

Details and patient eligibility

About

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.

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups, including a placebo group

GROUP1
Active Comparator group
Description:
group receiving single dose fenofibrate
Treatment:
Drug: Fenofibrate
GROUP2
Active Comparator group
Description:
group receiving double dose fenofibrate
Treatment:
Drug: Fenofibrate
GROUP3
Placebo Comparator group
Description:
photo therapy only
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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