NCT01624012已完成不适用
Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Duration of inspired oxygen supply
研究概览
简要总结
The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.
The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.
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
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •postconceptional age 28+0 - 36+6
- •need of ncpap treatment and inspired oxygen for at least 60 minutes
排除标准
- •severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
- •any condition which prevents insertion of naso/orogastric tube
结局指标
主要结局
Duration of inspired oxygen supply
时间窗: 30minutes- 3weeks
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
次要结局
- Duration of parenteral nutrition(3 weeks)
- Blood gas analyses(3 weeks)
- Duration of noninvasive ventilation(30 minutes - 3 weeks)
- Fraction of inspired oxygen(0, 1, 3 and 6hours, after which every 6 hours)
研究者
Merja Ålander
Principal investigator
University of Oulu
研究点 (2)
Loading locations...
相似试验
已完成
不适用
NIV-NAVA vs NIV-PS/PC in Respiratory InsufficiencyRespiratory InsufficiencyAcute Respiratory InsufficiencyNCT02592512Vejle Hospital30
招募中
不适用
Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of BronchiolitisBronchiolitisNCT06053684Montefiore Medical Center130
已完成
不适用
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants StudyEndotracheal ExtubationInfant, PrematureNCT02590757Seoul National University Hospital78
已完成
2 期
Physiologic Comparison Between NIV-NAVA and PS in Preterm InfantsNoninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm InfantsNCT01877720Seoul National University Hospital16
已完成
不适用
Performance of Neurally Adjusted Ventilatory Assist (NAVA) During Spontaneous Breathing TrialRespiratory FailureNCT01337271University of Sao Paulo General Hospital20