EUCTR2009-012203-26-FR进行中（未招募）1 期
Efficacy and safety of inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •A gestational age of 23 0/7- 27 6/7 weeks, a postnatal age a postnatal age < 12 hours, the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP), singleton or second born in case of multiple pregnancy and parental consent for participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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 including all congenital pulmonary malformations, 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 aforementioned reasons will be left to the discretion of the attending physician.
- •Other exclusion criteria are: nosocomial pulmonary viral infections and hypersensitivity to any component of inhaled budesonide (budesonide itself, glycerol, ethanol, HFA-134A (norflurane)).
研究者
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