NCT03518762已完成不适用
Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome
Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Need for invasive mechanical ventilation or death
研究概览
简要总结
This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.
详细描述
Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 27 weeks and ≤ 32 weeks
- •Appropriate for gestational age
- •Weight >800 grams
排除标准
- •Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
- •Fetal hydrops
结局指标
主要结局
Need for invasive mechanical ventilation or death
时间窗: From birth up to 72 hours of life
Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death
次要结局
- Bronchopulmonary dysplasia(Assessed at 36 weeks postmenstrual age or discharge, whichever came first)
- Duration of invasive mechanical ventilation(From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days)
- Pneumothorax(From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days)
研究者
Douaa El Saied El Sherbiny
Doctor
Kasr El Aini Hospital
研究点 (1)
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