跳至主要内容
临床试验/CTRI/2015/03/005631
CTRI/2015/03/005631招募中不适用

Randomized Control trial of Continuous positive airway pressure versus Standard care in neonates with moderate meconium aspiration syndrome in reducing the need for invasive ventilation

Fernandez Hospital2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2014年10月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
132
试验地点
2
主要终点
Need for invasive mechanical ventilation in the first 7 days of life will be the primary outcome.

研究概览

简要总结

Meconium aspiration syndrome is one of the commonest cause of morbidity in term neonates. Neonates with moderate MAS will be randomized either into CPAP  or standard group after taking written consent from parents. In CPAP group, enrolled neonate will be kept on continuous positive airway pressure (CPAP) according to protocol while in standard group, neonate will be kept on oxygen by hood/ ventilator depending on the respiratory status. They will be monitored for the clinical outcomes till discharge/death. All the neonates will be managed according to standard protocols for the hemodynamic stability and other problems.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Open Label

入排标准

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

入选标准

  • All neonates born with MSL, developed respiratory distress with Downe’s score > 4 and having typical chest X-ray appearance with •Oxygen saturation <90% on room air •Downe’s score > 4 •Gestation >35 weeks and birth weight >2kgs •Less than 6 hours of life.

排除标准

  • Neonates with poor respiratory efforts requiring intubation and ventilation, pulmonary air leak syndromes, shock requiring inotropic support and blood pressure with MAP<35mmHg orMajor malformations which can comprise the cardio-respiratory status of neonate.

结局指标

主要结局

Need for invasive mechanical ventilation in the first 7 days of life will be the primary outcome.

时间窗: 7 days of life

次要结局

  • Duration of ventilation(till discharge /death)
  • Duration of hospitalization(Till discharge / death)
  • Death(till discharge)
  • Duration of oxygen(till discharge / death)
  • Pneumothorax(till the baby on CPAP)

研究者

发起方
Fernandez Hospital
申办方类型
Research institution and hospital

研究点 (2)

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