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临床试验/CTRI/2024/02/062501
CTRI/2024/02/062501尚未招募2/3 期

"Comparison of the clinical outcomes of newborns after omission STIMULATION from initial steps of resuscitation VS Standard neonatal resuscitation program : A Randomized Control Trial"

未提供1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年2月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
92
试验地点
1
主要终点
duration of hospital stay

研究概览

简要总结

The goals of neonatal resuscitation are to prevent the morbidity and mortality associated with hypoxic ischemic tissue injury and also to re establish adequate spontaneous respiration and cardiac output.

AIM is to simplify the NRP protocol by omission of stimulation from Initial steps of resuscitation. and find the outcome of the newborn.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Not breathing or crying at birth.

排除标准

  • Major congenital heart, CNS or respiratory system anomaly Not giving consent.

结局指标

主要结局

duration of hospital stay

时间窗: baseline | 4weeks

development of long term neurological deficits

时间窗: baseline | 4weeks

次要结局

  • 1. Normal healthy baby(2. Hypoxic Ischemic Encephalopathy stages 1,2,3)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Mudrika Gupta

Ganesh Shankar Vidyarthi Memorial Medical College

研究点 (1)

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