Comparison Of Bubble CPAP (Variable Flow CPAP) Vs Pressure Sources Of CPAP In Preterm Infants An Open Labelled Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS Bhopal
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.CPAP failure in the first 72 hours of birth
研究概览
简要总结
Respiratory distress syndrome (RDS) is the most common pulmonary aliment in preterm newborns, and the incidence may reach up to 80 per cent in the extreme preterm populations (less than 28 weeks). With the antenatal corticosteroid in preterm pregnancy, early onset respiratory distress in preterm newborns is supported with continuous positive airway pressure support (CPAP) which has gained popularity due to its low cost, non- invasive respiratory support. Following the widespread adoption of these interventions over the past several decades, the principle from of respiratory support for preterm infants with or at risk of RDS has moved from mechanical ventilation via an endotracheal tube to non- invasive ventilation. However, given the level of certainty about the effect of bubble CPAP versus other pressure sources on the risk of treatment failure and most associated morbidity and mortality for preterm infants, further trials are needed to provide evidence of sufficient validity and practice. This trial aims at comparing the two common varieties of CPAP for their clinical outcomes as the primary mode of respiratory therapy.
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 28.00 Day(s)(—)
- 性别
- All
入选标准
- •Preterm (less than 37 completed weeks at birth) who develop early onset respiratory distress requiring CPAP within 6 hours of birth.
排除标准
- •Surgical anomalies of chest and abdomen
- •Syndromic newborns
- •Preterm infants who require delivery room intubation and early surfactant replacement therapy.
- •Perinatal asphyxia with encephalopathy or cord pH < 7
- •Pneumothorax or air-leaks prior to enrolment.
结局指标
主要结局
1.CPAP failure in the first 72 hours of birth
时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days
2.Need of mechanical ventilation
时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days
3.Incidence of hypoxic respiratory failure
时间窗: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days
次要结局
- 1.Duration of respiratory support.(2.Need for surfactant replacement therapy)
研究者
Dr Cosmica Shah
AIIMS Bhopal
