Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist (NIV NAVA) Versus Nasal Continuous Airway Pressure (NCPAP) in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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
研究组 & 干预措施
NIV NAVA
Noninvasive ventilation in this group is practiced with NIV NAVA
干预措施: NIV NAVA (Device)
ncpap
Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.
干预措施: Nasal continuous positive airway pressure (Device)
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