EUCTR2009-012203-26-BE进行中（未招募）1 期
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSIS
niversity Children’s Hospital, Department of Neonatology0 个研究点目标入组 850 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 850
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
- •A gestational age of 23 0/7-27 6/7 weeks, a postnatal age < 12 hours, the requirement for any form of positive pressure support (mechanical or nasal ventilation or CPAP) and parental consent for participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •A clinical decision not to administer therapies (infant not considered viable), dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or an atrial septum defect). The clinical assessment of dysmorphic
- •features, congenital malformations, suspected congenital heart disease and the decision to exclude an infant for the mentioned reasons will be left to the discretion of the attending physician.
研究者
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