EUCTR2018-002383-38-FI进行中（未招募）1 期
Premedication for less invasive surfactant administration - LISA-Med
niversity of Oulu0 个研究点目标入组 40 人开始时间: 2018年10月9日最近更新:
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
- 40
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
- •Gestational age at birth =26 weeks; respiratory insufficiency managed with non-invasive respiratory support (nasal CPAP or high-flow); requirement for oxygen to maintain oxygen saturation (SpO2) in the target range and need for surfactant treatment (according to clinician’s assessment); if further doses of surfactant are needed, patient can be re-randomized
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy; maxillo-facial, tracheal or known pulmonary malformations; any known chromosomal abnormality or severe malformation; an alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)
研究者
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