ACTRN12611000916943终止未知
Multicentre randomised controlled trial in preterm infants 25-28 weeks gestation on continuous positive airway pressure of the effect of minimally-invasive surfactant therapy in comparison to standard care (continuation of CPAP) on the incidence of the composite outcome of death or physiological BPD.
Menzies Institute of Medical Research University of Tasamania0 个研究点目标入组 486 人开始时间: 2011年8月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 486
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- Hours 至 6 Hours（—）
- 性别
- All
入选标准
- •1. Gestational age 25-28 completed weeks 2. Requiring CPAP with signs of early respiratory distress. 3. CPAP pressure of 5-8 cm H2O and FiO2 >=0.30. 4. Less than 6 hours of age. 5. Agreement of the Treating Physician in charge of the infant’s care. 6. Signed parental consent.
排除标准
- •1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis.
- •2. Congenital anomaly or condition that might adversely affect breathing.
- •3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia).
- •4. Lack of availability of an OPTIMIST treatment team.
研究者
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