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临床试验/CTRI/2025/08/093590
CTRI/2025/08/093590尚未招募不适用

Endotracheal Suctioning versus No Suctioning for Postnatal Stabilization of Non-vigorous Neonates Born through Meconium Stained Liquor: A Randomized Controlled Trial

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
试验地点
1
主要终点
Peripheral oxygen saturation

研究概览

简要总结

This study is a randomized, parallel group trial comparing the effect of endotracheal suctioning versus no suctioning on postnatal cardiorespiratory stability of non vigorous neonates delivered through meconium stained liquor at birth. The primary outcome measures will be mean peripheral oxygen saturation at five minutes of life. The secondary outcomes will be cardiorespiratory parameters and regional cerebral oxygen saturation at 10 minutes and 1 hour of life, need and duration of respiratory support, morbidities and mortality during hospital stay and neurological examination at discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 90.00 Day(s)(—)
性别
All

入选标准

  • Non-vigorous singleton neonates of gestational age equal to or more than 34 weeks delivered through meconium stained liquor.

排除标准

  • Major congenital malformations
  • Refusal of consent.

结局指标

主要结局

Peripheral oxygen saturation

时间窗: at 5 minutes of life

次要结局

  • A. Immediate(1. Minute-specific heart rate & peripheral oxygen saturation)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Poonam Singh

All India Institute of Medical Sciences Rishikesh

研究点 (1)

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