Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 9
- 主要终点
- Compliance with the study protocol
研究概览
简要总结
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
详细描述
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
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
- 年龄范围
- — 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants delivered in a specially equipped resuscitation room(s)
- •<28 weeks gestational age by best obstetric estimate before delivery
- •Requiring resuscitation
排除标准
- •No known major congenital anomalies
- •Decision made not to provide full resuscitation
研究组 & 干预措施
CPAP/PEEP Intervention
Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
干预措施: CPAP/PEEP (Device)
Control
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
干预措施: Standard management practices (Device)
结局指标
主要结局
Compliance with the study protocol
时间窗: 6 months
次要结局
- Extent of resuscitation needed(Until admission to NICU)
- Bronchopulmonary dysplasia (BPD)(36 weeks of life)
- Number and duration of intubation attempts(Until admission to the NICU)
- Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room(Until admission to the NICU)
- Five minute Apgar(5 minutes after birth)
- Total duration of mechanical ventilation(Until hospital discharge or 120 days of life)
- Proportion of infants requiring surfactant(1 day of life)