Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
研究概览
简要总结
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
详细描述
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants with birth weight >500 gm.
- •Gestational age >24 completed weeks.
- •Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: 1) the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support; 2)the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- •No known lethal congenital anomaly or genetic syndromes.
- •Signed parental informed consent.
排除标准
- •Considered non-viable by clinician (decision not to administer effective therapies)
- •Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- •Infants known to require surgical treatment
- •Abnormalities of the upper and lower airways
- •Neuromuscular disorders
- •Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
结局指标
主要结局
Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
时间窗: At 7 days after non-invasive respiratorynsupport.
次要结局
- Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.(At 7 days, 28 days and at 36 weeks postmenstraul age)
研究者
Yuan Shi
Professor and Chief of Pediatrics
Third Military Medical University