To assess the efficacy of Extended Continuous Positive Airway Pressure in reducing the duration of respiratory support among preterm infants with respiratory distress syndrome—a pilot randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Time to wean off initial respiratory support to room air.
研究概览
简要总结
This randomised controlled trial evaluates the efficacy of extended CPAP in preterm infants with respiratory distress syndrome. Infants are stratified by gestational age and randomised into two groups: one receiving extended CPAP for an additional 24 hours and the other weaned based on unit protocols. The primary outcome is the time to wean off CPAP to room air. Secondary outcomes include bronchopulmonary dysplasia , neonatal mortality, length of hospital stay , time to full and oral feeding, re initiation of respiratory support, and re intubation in the first week. This open-label study aims to optimise CPAP duration and improve clinical outcomes.
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
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Gestational age less than 32 weeks treated for respiratory distress syndrome with or without surfactant and meeting the predesignated CPAP stability criteria will be included.
排除标准
- •major congenital anomalies, clinical suspicion of congenital pneumonia.
结局指标
主要结局
Time to wean off initial respiratory support to room air.
时间窗: 1. Baseline (start of intervention) | 2. Every 24 hours | 3. Specific days (day 3,7,14) | 4. At each weaning attempt | 5. At successful weaning(24 hours off support) | 6. Follow up at 24, 48 hours and 7 days after weaning
次要结局
- Incidence of bronchopulmonary dysplasia: The study will measure the incidence of bronchopulmonary dysplasia among participants(This is assessed at 36 weeks postmenstrual age)
- Neonatal mortality : the rate of death among neonates in the study.(This is assessed during initial hospital stay & up to 28 days of life.)
- Length of hospital stay: The duration of hospitalization from birth until discharge.(This is assessed from birth until first discharge from the hospital.)
- Time to full feeds: The period required for participants to achieve full enteral feeding.(This is assessed daily from birth until full enteral feeding is achieved.)
- Time to establish full oral feeding (paladai feeds or breastfeeds, off gavage feeds for more than 48 hours): The time taken to transition to & maintain full oral feeding.(This is assessed daily from birth until oral feeding is established)
- Re-initiation of respiratory support after weaning to room air: The frequency of restarting respiratory support after initial successful weaning to room air.
- Re-intubation during the first week of life: The incidence of re-intubation within the first seven days after birth.(This is assessed within the first 7 days of life.)
研究者
Dr Sathyamoorthy V P
JIPMER