A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)
研究概览
简要总结
When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. The breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. A new device called neurally adjusted ventilatory assist or NAVA is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. When using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. The objective of this pilot study is to compare this new breathing device called NAVA, to the equipment that is currently being used, called SiPAP, to support premature newborn's breathing after birth without a breathing tube. The investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid intubation.
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
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation
- •Diagnosis of RDS in the first 24 hours of life requiring respiratory support
- •Parental consent obtained
排除标准
- •Infants with a major congenital anomaly
- •Infants with pulmonary hypoplasia
- •Infants known or suspected to have a neuromuscular disorder
- •Infants less than 28+0 weeks GA
- •Intubated infants that are likely to require continued mechanical ventilation
- •Infants requiring vigorous resuscitation at birth, including chest compressions +/- cardiac medications
结局指标
主要结局
total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)
时间窗: one year
次要结局
- All cause mortality during the hospitalization(one year)
- Total duration of oxygen requirement(one year)
- Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation(one year)
- Number of doses of surfactant(one year)
- Time to reach full volume feeds (at least 120 ml/kg/day)(one year)
- Time to regain birth weight(one year)
- Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA(one year)
- Incidence of pneumothorax(one year)
- Incidence of nasal deformities, specifically nasal erosions(one year)
- Total length of hospital stay(one year)
研究者
Ravinder Kajla
Respiratory Therapist, Clinical Resource Therapist
Fraser Health