NCT02168257终止不适用
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Oxygenation
研究概览
简要总结
The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low Birth Weight Infant
- •Currently on continuous positive aireway pressure of 5-7 cm water pressure
- •Receiving continuous positive airway pressure support for > 24 hrs prior to enrollment
- •Fraction of inspired oxygen requirement of 23-50%
排除标准
- •Fraction of inspired oxygen > 50%
- •Congenital defects of head, pulmonary or cardiovascular systems
- •Chromosomal abnormalities/genetic syndromes
- •Invasive Surgical Procedure within 24 hrs prior to enrollment
- •Enrollment in separate clinical trial that has ongoing data collection
研究组 & 干预措施
RAM Cannula CPAP
Experimental
CPAP provided by RAM Cannula
干预措施: RAM Cannula (Device)
Binasal Prong CPAP
Active Comparator
CPAP provided by binasal prong
干预措施: Binasal Prong CPAP (Device)
结局指标
主要结局
Oxygenation
时间窗: 3 hrs
Pulse oximetry
Ventilation
时间窗: 3 hrs
transcutaneous carbon dioxide monitor
次要结局
- Esophageal pressure measurements(3 hrs)
- Apnea(3 hrs)
研究者
研究点 (2)
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