NCT01318824Unknown3 期
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
研究概览
简要总结
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.
详细描述
Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.
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 (Care Provider)
入排标准
- 年龄范围
- — 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: 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 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
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
时间窗: At 7 days, 28 days and at 36 weeks postmenstraul age
get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
次要结局
- the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure(At 7 days, 28 days and at 36 weeks postmenstraul age)
研究者
研究点 (1)
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