Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- failure of NIV
研究概览
简要总结
The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.
The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.
详细描述
Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.
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
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit
排除标准
- •who are intubated in delivery room or neonatal intensive care unit before randomization
- •with congenital anomaly
- •patients who require NIV more than 3 days
结局指标
主要结局
failure of NIV
时间窗: 1 year
patients who require endotracheal intubation after NIV treatment
次要结局
- ventilation duration(3 days)