EUCTR2013-005429-21-GB进行中（未招募）1 期
Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure (CPAP) - The OPTIMIST-A Trial
Menzies Research Institute Tasmania0 个研究点目标入组 606 人开始时间: 2015年7月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 606
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Preterm infants of gestation 25 weeks 0 days to 28 weeks 6 days who are inborn and admitted to the NICU of a participating study centre, and meet all of the following criteria:
- •1. Requiring CPAP because of respiratory distress.
- •2. CPAP pressure of 5-8cm H2O and FiO2 >=0.30
- •3. Less than 6 hours of age.
- •4. Agreement of the Treating Physician in charge of the infant's care.
- •5. Signed parental consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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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