Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation
研究概览
简要总结
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
详细描述
There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation <32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation less than 32 weeks
- •Birth weight less than 1500 g
- •Age less than seven days
- •First extubation attempt.
排除标准
- •A neonate having any of the following will be excluded from the study-
- •Severe birth asphyxia defined as need for chest compression for more than 30 seconds
- •Suspected congenital neuromuscular disorder
- •Major congenital malformation
- •Grade 3/4 interventricular haemorrhage
结局指标
主要结局
Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation
时间窗: Till 72 hours after extubation
次要结局
- Time to extubation failure in hours.(till extubation failure within first 72 hours after extubation)
研究者
Ramesh K Agarwal
Associate Professor
All India Institute of Medical Sciences, New Delhi