Nasal mask versus Nasal prongs in the delivery of Continuous positive airway pressure in preterm infants – an open label randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application
研究概览
简要总结
This study is a randomized, open label parallel group single centre study comparing the efficacy and safety of CPAP delivery through nasal masks versus bi-nasal prongs in preterm babies with respiratory distress syndrome. The efficacy will be measured as the area under the curve of FiO2 requirement against time during the first 72 hours of CPAP application and safety will be measured by the incidence of nasal trauma and air leaks in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm babies of 26+0 – 32+6 weeks of gestation Respiratory distress requiring CPAP within 6 hours of life Informed parental consent.
排除标准
- •Major congenital malformations Any known anomaly known to interfere with delivery of CPAP such as congenital diaphragmatic hernia, trachea oesophageal fistula, choanal atresia, cleft palate and nasal deformities, severe cardiovascular instability.
结局指标
主要结局
1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application
时间窗: 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application | 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP
2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP
时间窗: 1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application | 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP
次要结局
- 1.Proportion of babies requiring intubation in the first 72 hours of life(2.Proportion of babies who develop nasal trauma)