NCT01926106已完成不适用
Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome
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 286 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- incidence of intubation
研究概览
简要总结
In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.
详细描述
After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild-moderate respiratory distress syndrome
- •requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95%
- •a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)
排除标准
- •pneumothorax
- •pneumomediastinum
- •surgical diseases
- •cardiac diseases
- •intraventricular hemorrage
- •major congenital defects
研究组 & 干预措施
nIPPV
Experimental
the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)
干预措施: nIPPV (Device)
nCPAP
Active Comparator
the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)
干预措施: nCPAP (Device)
结局指标
主要结局
incidence of intubation
时间窗: 48h
次要结局
- incidence of BPD(1 month)
研究者
Chen Long,MD
Prof;MD
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
研究点 (1)
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