Clinical trial NCT06451900: Role of Fenofibrate in Neonatal Jaundice
Official title: Prophylactic Role of Fenofibrate in Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Jaundice
Keywords: neonatal jaundice
prophylaxis
fenofibrate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: full-term (37 to 41 weeks),Appropriate for gestational age weight between 2500 to 3500 gm infants with neonatal hyperbilirubinemia not reaching thel evel of phototherapy.The participants in our study will be divided in to three groups: Group A: full term neonates received a single oral dose of 10 mg/kg of non- micronized fenofibrate Group B: full term neonates received two oral doses of 10 mg/kg of non - micronized fenofibrate.

Group C: full term neonates received equivalent amount of distilled water.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: change in total serum bilirubin
timeFrame: up to 5 days
measure: start of phototherapy
timeFrame: up to 5 days
measure: start of exchange transfusion
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbassia
Study officials:
References: