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临床试验/NCT03630367
NCT03630367撤回4 期

Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants

Assiut University1 个研究点 分布在 1 个国家开始时间: 2018年10月3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
撤回
试验地点
1
主要终点
the mean difference in the Apgar score after birth

研究概览

简要总结

The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome

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)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women between 30-37 weeks
  • singleton pregnancy

排除标准

  • congenital malformed fetus
  • Extreme premature

研究组 & 干预措施

study group

Experimental

women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous

干预措施: Dexamethasone (Drug)

study group

Experimental

women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous

干预措施: L-Carnitine 1G/5mL Injection (Drug)

control group

Active Comparator

women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous

干预措施: Dexamethasone (Drug)

结局指标

主要结局

the mean difference in the Apgar score after birth

时间窗: 1 minute

Assessment of fetal general condition

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

Ahmed Mohamed Abbas

Principal investigator

Assiut University

研究点 (1)

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