NCT01471431终止不适用
A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- time to successful extubation
研究概览
简要总结
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).
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
- None
入排标准
- 年龄范围
- 48 Hours 至 14 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birthweight >500g and<1500g.
- •Postmenstrual age <34 weeks
- •Mechanically ventilated >48 hours
- •Never successfully extubated
排除标准
- •Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
- •Known or suspected airway anomalies
- •Severe congenital malformations
- •Need to remain intubated for other reasons (i.e. having surgery)
- •Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
研究组 & 干预措施
Spontaneous breathing trial
Experimental
The spontaneous breathing trial will determine the extubation readiness of the subject.
干预措施: spontaneous breathing trial (Other)
Usual care
No Intervention
Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.
结局指标
主要结局
time to successful extubation
时间窗: 34 weeks postmenstrual age
The time from intubation (if \>48 hours) to successful extubation (if \> 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)
次要结局
- bronchopulmonary dysplasia(36 weeks postmenstrual age)
- extubation failure rate(34 weeks postmenstrual age)
研究者
研究点 (2)
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