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临床试验/CTRI/2017/03/008156
CTRI/2017/03/008156
已完成
3 期

Fluid restriction for term infants with hypoxic- ischaemic encephalopathy following perinatal asphyxia-a randomized controlled trial

Diamond Jubilee Society Trust1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年3月4日最近更新:

概览

阶段
3 期
状态
已完成
入组人数
210
试验地点
1
主要终点
PRIMARY OUTCOME: Neonatal mortality or severe neurodevelopmental disability at discharge.

概览

简要总结

Perinatal asphyxia and associated hypoxic ischaemic encephalopathy is an importnat cause of perinatally acquired brain damage in term infants.the rationale of fluid restriction in perinatal asphyxia is to avoid fluid overload and exacerbation of cerebral oedema.Restriction of fluid intake in cases of perinatal asphyxia is being practiced with experience in children and adults and animal experiments.Hence quantitative recommendation for fluid restriction cannot be obtained from above studies. We aim to study the effct of fluid restriction in term infants with perinatal asphyxia on neurological outcomes.Primary outcomes to be measured are neonatal mortality or severe neurodevelopmental disability at discharge.the secondary outcomes to be measured include electrolyte imbalance,oliguria,abnormal renal function,seizures and CT/MRI findings consistent with asphyxia.This is a randomized controlled trial to be completed  over a period of 2 years with 210 study participants with perinatal asphyxia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
1.00 Day(s) 至 3.00 Day(s)(—)
性别
All

入选标准

  • neonate with perinatal asphyxia.

排除标准

  • neonate with congenital malformation.

结局指标

主要结局

PRIMARY OUTCOME: Neonatal mortality or severe neurodevelopmental disability at discharge.

时间窗: at discharge.

次要结局

  • 1)electrolyte disturbances(2)Urine output1ml/kg/h during the first three days of life.)

研究者

申办方类型
Research institution

研究点 (1)

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