Comparison of two levels of positive end expiratory pressure for delivery room resuscitation in preterm neonates of less than 32 weeks’ gestation : a 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
- 80
- 试验地点
- 1
- 主要终点
- 1.Incidence of endotracheal intubation within 72 hrs of birth
研究概览
简要总结
The current strategies of preterm lung recruitment at birth remain ineffective especially in preterms who require delivery room resuscitation. The AAP advocates a prompt creation of FRC for positive outcomes. On this principle , the use of PEEP with resuscitation devices for optimal benefits in non vigorous preterms is being practiced. Provision of PEEP has decreased burden of respiratory interventions and improved outcomes. While the range of distending pressures are wide , lower ranges are used routinely. This trial is planned to compare clinical benefits of resuscitating preterms of less than 32 weeks of gestation with recommended pressures of PEEP at lower ranges of 5-6 cm of water versus 7-8 cm of water in delivery room till stabilization.
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
- •1.Inborn preterm infants less than 32 weeks gestation requiring resuscitation in delivery room.
排除标准
- •1.Antenatally diagnosed major congenital anomalies or chromosomal disorders.
- •2.Infants born via MTP.
- •3.Hydrops fetalis or pulmonary hypoplasia.
- •4.Preterm new born with surgical conditions.
- •5.Antenatal diagnosis of conditions resulting in poor prognosis.
- •6.Peri viable new borns.
结局指标
主要结局
1.Incidence of endotracheal intubation within 72 hrs of birth
时间窗: At 2,4,6 and then 6 hourly till 72 hours
2.trends of oxygenation(modified oxygenation index SpO2/FiO2) in first 72 hrs of birth
时间窗: At 2,4,6 and then 6 hourly till 72 hours
3.Incidence of hypoxic respiratory failure in first 72 hrs of birth in mechanically ventilated new born
时间窗: At 2,4,6 and then 6 hourly till 72 hours
次要结局
- 1. Need for surfactant replacement therapy in first 72 hrs.(2.CPAP failure rate in first 72 hrs after CPAP therapy initiation in NICU.)
研究者
Dr Sattiraju Sarvani
AIIMS Bhopal