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临床试验/NCT06451900
NCT06451900已完成4 期

Prophylactic Role of Fenofibrate in Neonatal Jaundice

Ain Shams University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
change in total serum bilirubin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blinded controlled trial

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

fenofibrate single dose

Experimental

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

干预措施: Fenofibrate (Drug)

fenofibrate double dose

Experimental

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

干预措施: Fenofibrate (Drug)

placebo

Placebo Comparator

full term neonates will receive equivalent amount of distilled water.

干预措施: placebo (Other)

结局指标

主要结局

change in total serum bilirubin

时间窗: up to 5 days

Decline in total serum bilirubin values per unit of time after 12, 24, 36, 48 hours, 5 days from intervention.

start of phototherapy

时间窗: up to 5 days

time at which phototherapy will be initiated from receiving the drug and till 5 days later

start of exchange transfusion

时间窗: up to 5 days

time at which patient needed to perform exchange transfusion after receiving the drug till five days later

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Ibrahim

Assistant Professor of Paediatrics, Ain Shams university

Ain Shams University

研究点 (1)

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