A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Delta heart rate (beats/minute) during each ventilation sequence
研究概览
简要总结
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.
详细描述
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.
The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.
排除标准
- •Babies with major deformities not deemed to be viable.
- •Missing parental consent
研究组 & 干预措施
Upright Resuscitator with PEEP
Ventilation with the Upright Resuscitator with PEEP
干预措施: Upright Resuscitator with PEEP (Device)
Upright Resuscitator
Ventilation with the Upright Resuscitator (without PEEP)
干预措施: Upright Resuscitator (Device)
结局指标
主要结局
Delta heart rate (beats/minute) during each ventilation sequence
时间窗: 10 minutes
次要结局
- Neonatal outcome dead versus alive(Up to 24 hours)
- Time to cessation of ventilation(Up to 1 hour)
- Time to heart rate above 140 beats/minute(Up to 1 hour)
- Mean ariway pressures given(Up to 1 hour)
- Time to detection of exhaled CO2 above 1% and 4%(Up to 1 hour)