NCT01721629已完成不适用
Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial
Aarhus University Hospital12 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 12
- 主要终点
- Weight at a gestational age of 40 weeks
研究概览
简要总结
The aim of this study is to investigate two different strategies for the withdrawal of CPAP in preterm infants born before 32 weeks of gestation.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 32 weeks at birth
- •Current gestational age > 28+6 weeks
- •Nasal CPAP for > 24 hours
- •Nasal CPAP pressure < 8 cmH2O
- •Oxygen requirement < 30% and not increasing
- •Respiratory rate < 70 per minute
- •Less than 3 episodes of oxygen saturation < 70% or a heart rate < 70 beat per minute in the preceding 24 hours
- •Tolerates time off CPAP during cares (up to 15 minutes)
排除标准
- •Congenital malformations of the heart (except patent ductus arteriosus, atrial septal defect and patent foramen ovale), lung, and gastrointestinal tract
- •Surgical procedures performed on the gastrointestinal tract
- •Known or suspected to have congenital neuromuscular disease
- •Known or suspected syndrome
结局指标
主要结局
Weight at a gestational age of 40 weeks
时间窗: Up to 16 weeks
次要结局
- Parental anxiety(Up to 6 months)
- Duration of nasal CPAP therapy(Up to 6 months)
- Length of stay in the hospital(Expected median 54 days)
- Weight at completed withdrawal of nasal CPAP(From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days)
- Duration of oxygen treatment(Up to 6 months)
- Occurence of bronchopulmonary dysplasia(Up to 12 weeks)
- Depression in parents(Up to 6 months)
研究者
Christina Friis Jensen
MD, Ph.D. student
Aarhus University Hospital
研究点 (12)
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