Role of Fenofibrate in Neonatal Jaundice

NCT ID: NCT06451900

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2023-11-30

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.

Detailed Description

Neonatal jaundice is a common disease in neonates. Based on current statistics, 60% of term neonates and 80% of preterm neonates suffer from jaundice during the first week of birth The normal bilirubin level of the umbilical cord is 1-3 mg/dL, which increases to 5-6 mg/dL on the second to fourth days after birth and decreases to less than 2 mg/dL on the 5th to 7th days after birth .

Destruction of red blood cell and its hemoglobin component produces bilirubin which is then conjugated to a soluble form and excreted. In neonates, this becomes more significant because of high red cell mass and relative immaturity for bilirubin conjugation.

Free bilirubin deposits in the skin and mucous membranes and produces jaundice. It may also deposit in the brain where it has been implicated in causing transient dysfunction and, occasionally, permanent neuronal damage.

Every year, a huge hospital cost is imposed on parents for the treatment of neonatal jaundice. Moreover, it leads to the mother-child separation and subsequent mental health problems. Proven treatments for jaundice include phototherapy and blood exchange transfusion in which each one has its own complications . medication has also been used to prevent and treat neonatal jaundice Including IVIG, protoporphyrin, phenobarbital and fenofibrate.

Fibrates have been used for several years as a hypolipidemic drug in adults.They exert their hypolipidemic activity through peroxisome proliferator- activated receptor activation The value of this mechanism in the reduction of bile acid synthesis had been demonstrated by experimental study of cindrouk and colleagues . Fibrates also increase bilirubin conjugation and excretion via induction of glucuronyl transferase activity. Its potency to induce bilirubin conjugation is very high. Fibrates are aclass of phenoxy iso butyric acid derivatives including clofibrate and fenofibrate. Fenofibrate is one of the fibrates it has inducing effect on glucuronyl transferase activity, it increases bilirubin conjugation and excretion making it possible to be used in the treatment of neonatal jaundice via influencing bilirubin metabolism. Fenofibrate is very similar to clofibrate in its action. However, it is simply more accessible and has more safety profile, therefore, it is much safer to be given to children than clofibrate. Fenofibrate has been used in treatment of neonatal jaundice the researchers aim to explore its efficiency as a prophylactic agent in neonates with neonatal jaundice not reaching the level of phototherapy.

Conditions

Neonatal Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

fenofibrate single dose

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

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: 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

fenofibrate double dose

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

Group Type: EXPERIMENTAL

Fenofibrate

Intervention Type: 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

placebo

full term neonates will receive equivalent amount of distilled water.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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

Interventions

Fenofibrate

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Other Intervention Names

lipid lowering drug; control

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ibrahim

Assistant Professor of Paediatrics, Ain Shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, Abbassia, Egypt

Countries

Egypt

Other Identifiers

prophylactic fenofibrate

Identifier Type: -

Identifier Source: org_study_id