Magnesium sulfate as an adjunct to therapeutic hypothermia in the management of term infants with hypoxic ischemic encephalopathy: A randomized controlled trial.

JIPMER Puducherry1 个研究点分布在 1 个国家目标入组 134 人开始时间: 2018年7月16日最近更新: 2020年7月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方: JIPMER Puducherry
入组人数: 134
试验地点: 1
主要终点: Neonatal mortality and/or abnormal neurodevelopmental outcome at 1 year of age

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia(or cooling) to babies who are asphyxiated at birth provides additional benefit to the babiesâ€™survival and outcome compared to cooling alone

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, variable
盲法: Open Label

入排标准

年龄范围: 0.00 Day(s) 至 1.00 Day(s)（—）
性别: All

入选标准

•Inclusion criteria A plus B and any one of C A.
•Inborn babies with Gestational age more than or equal to 37 weeks with Arterial blood gas(Umbilical cord or 1st postnatal hour) pH less than or equal to 7.0 or base deficit more than or equal to 12 meq/L B.
•Presence of moderate to severe encephalopathy C.
•Any one of the below mentioned criteria:
•APGAR less than or equal to 5 at 10 minutes
•Evidence of fetal distress
•Assisted ventilation for at least 10 minutes after birth
•Evidence of any organ dysfunction
•History of acute perinatal event.

排除标准

•Exclusion criteria Infants more than 6 hours of age.

结局指标

主要结局

Neonatal mortality and/or abnormal neurodevelopmental outcome at 1 year of age

时间窗: Neonatal mortality at 28 days of life and abnormal neurodevelopmental outcome at 1 year of age

次要结局

a.Neonatal mortality(b.Major neurodevelopmental disability at 1 year of age)

研究者

发起方

JIPMER Puducherry

申办方类型

Research institution and hospital

研究点 (1)

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