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临床试验/NCT04868019
NCT04868019Unknown不适用

Fenofibrate in Indirect Neonatal Hyperbilirubinemia

Shaheed Zulfiqar Ali Bhutto Medical University0 个研究点目标入组 60 人开始时间: 2021年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
主要终点
Duration of phototherapy

研究概览

简要总结

Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.

详细描述

Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method. Demographics like name, age (hours), gender, birth weight, and gestational age will be noted. Solutions will be prepared in the required strengths and labeled accordingly. Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. All this information will be recorded on proforma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method.

入排标准

年龄范围
2 Days 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group A

Experimental

Groups A will receive solution A .i.e fenofibrate suspension

干预措施: Fenofibrate Capsules (Drug)

Group B

Placebo Comparator

Group B will receive solution B i.e placebo.

干预措施: Fenofibrate Capsules (Drug)

结局指标

主要结局

Duration of phototherapy

时间窗: 6 months

It is the total time from admission (Serum bilirubin level ≥15 and ≤20 mg/dl) until phototherapy is no longer needed (Serum bilirubin level \< 10mg/dl) and is measured in hours.

次要结局

  • Serum bilirubin level(6 months)

研究者

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

Dr Nighat Haider

Assistant Professor

Shaheed Zulfiqar Ali Bhutto Medical University

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