Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Participants With Extubation Failure
研究概览
简要总结
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.
详细描述
Primary outcome: Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation Secondary outcome: Number of infants that reach 21% inspired oxygen during initial study period Secondary outcome: Apnea/bradycardia events in the initial study period Secondary outcome: Mean oxygen requirement following initial study period
Population: Infants born at <=1250 grams birth weight but >= 500 grams birth weight
Randomization: Equal allocation stratified by gestational age (<27 weeks, >=27 weeks)
Study diagram:
72h 24h X---------->X1----------->Y2 Y---------->Y1----------->X2 Infants will be randomly assigned to treatment X (BabiPlus, control group) or treatment Y (B&B Bubbler, intervention group). The primary outcome is bubble CPAP failure during the first 72 hours following extubation, measured at time point 1 in the diagram. Bubble CPAP failure is defined as requiring re-intubation or non-invasive positive pressure ventilation (NIPPV), requiring FiO2 of >60% for one hour or a pCO2 measurement of >65 mm Hg. For those infants that remain on CPAP during the initial study period, the number that reach 21% inspired oxygen for >12 consecutive hours will be compared between groups. This difference will also be analyzed using a Chi square test.
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
- None
入排标准
- 年龄范围
- 1 Day 至 100 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant delivered at >=500 grams and <=1250 grams birth weight.
- •Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
- •Infant has received exogenous surfactant during mechanical ventilation.
排除标准
- •Decision by attending physician to redirect to comfort care
- •Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
- •Birth weight >1250 grams or <500 grams.
- •Non-English speaking parents. -
结局指标
主要结局
Number of Participants With Extubation Failure
时间窗: Within 72 hours of extubation
Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation
次要结局
- Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly(96 hours)
研究者
Marya Strand, MD
Associate Professor, Pediatrics
St. Louis University