"RAM cannula versus Nasal mask for providing Continuous positive airway pressure (CPAP) in preterm Infants. A non inferiority Trial"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- CPAP failure within 72 hours
研究概览
简要总结
Nasal Continuous positive airway pressure (CPAP)is the standard noninvasive respiratory support for preterm babies with respiratory distress.Different interfaces including binasal prongs, nasal mask and RAMcannula are used for providing CPAP to preterm infants. Nasal injuryis a common problem with the interfaces used. Nasal prongs have been used since a long time, although effective, use of binasal prongs hasbeen associated with more nasal trauma.
CPAP delivered via nasal mask has been the standard of care for preterm infants with respiratory distress due to less CPAP failure and less nasal trauma.
Off label use of RAM cannula is now a days very common due to ease of use and perception of decreased nasal injury. It is being used in our NICU also since long. We have observed less CPAP failure and nasal injury with RAM cannula. Also cost of RAM cannula is much less.
The aim of this study is to conduct a non inferiority trial comparing effectiveness of RAM cannula versus nasal mask in preterm infants with respiratory distress.We hypothesize that RAM cannula is no inferior to nasal mask for CPAP in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •preterm infants with respiratory distress within 6 hours of birth.
排除标准
- •Requirement of mechanical ventilation at birth
- •Major congenital malformation.
结局指标
主要结局
CPAP failure within 72 hours
时间窗: CPAP failure within 72 hours
次要结局
- Nasal Injury(till discharge)
- duration of CPAP & oxygen therapy
- Incidence of BPD, ROP, IVH, airleaks, NEC(till discharge)