NCT02590757已完成不适用
Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Extubation failure
研究概览
简要总结
This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of 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
- 年龄范围
- 2 Days 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postconceptional age less than 30+0 weeks
- •infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3
排除标准
- •conditions which will decrease life expectancy
- •major anomalies which will decrease life expectancy
- •any anomalous conditions which involve upper and lower airway
- •neuromuscular disease
结局指标
主要结局
Extubation failure
时间窗: extubation - 72 hours
Failure criteria * pH \< 7.2 with pCO2 \> 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings * Severe apnea event requiring bag and mask resuscitation * FiO2 \>0.6 to maintain SpO2 ≥ 88% after extubation * Frequent desaturations (\< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0
次要结局
- FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation(extubation - 7 days)
- Bronchopulmonary dysplasia(postmenstrual age 36 weeks)
- Duration of hospital stay(postmenstrual age 40 weeks (until discharge))
- Severe apnea event requiring bag and mask resuscitation(extubation - 7 days)
- pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings(extubation - 7 days)
- Duration of noninvasive ventilation(postmenstrual age 40 weeks (until discharge))
- Duration of inspired oxygen supply(postmenstrual age 40 weeks (until discharge))
- Adverse events(extubation - 3days)
研究者
Han-Suk Kim
Professor, Director of Neonatal Intensive Care Unit
Seoul National University Hospital
研究点 (2)
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