Nasal continuous positive airway pressure with RAM cannula versus nasal mask in reducing the need for invasive mechanical ventilation in preterm neonates
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Need for invasive mechanical ventilation within 72 hours of nCPAP application
研究概览
简要总结
Following thesis is on comparing nasal interface RAM cannula and nasal mask for application of nasal continuous positive airway pressure (nCPAP) in preterm neonates less than 34 weeks of gestation with respiratory distress within 6 hours of life. nCPAP is a type of non invasive ventilation. Both these interfaces are currently in use in our institute in neonatal intensive care unit. This thesis is about comparing both the interfaces about their failure rate and neonantes requiring invasive mechanical ventilation as primary objective and secondary objective is incidence of nasal trauma in both the interfaces. Inclusion criteria will be all inborn neonates with gestation age less than 34 weeks having respiratory distress syndrome within 6 hours of life. Each neonate will be given nCPAP via RAM cannula or nasal mask and will be followed for 72 hours of life. Exclusion criteria will be major congenital malformations, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal birth asphyxia with 5 min Apgar score less than 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Day(s)(—)
- 性别
- All
入选标准
- •Inborn preterm neonates less than 34 weeks of gestation with respiratory distress syndrome within 6 hours of life.
排除标准
- •Major congenital malformation, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal asphyxia with 5 min Apgar score less than 3.
结局指标
主要结局
Need for invasive mechanical ventilation within 72 hours of nCPAP application
时间窗: 72 hours
次要结局
- Incidence and severity of Nasal trauma(72 hours)
研究者
Dr Nikhil Srivastav
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
