EUCTR2013-003889-14-GB进行中（未招募）1 期
A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants - Treat Infections In Neonates 2 v1.0
Institut National de la Santé et de la Research Médicale0 个研究点目标入组 810 人开始时间: 2015年6月12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
- 810
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) Pre-term, =28 weeks gestational age (i.e. 28 weeks and 6 days, including infants born as one of a multiple birth)
- •b) Requirement for respiratory support within 12hrs of birth (intubated, or by non-invasive mechanical ventilation inc. continuous positive airway pressure)
- •c) Presence of an indwelling intravenous line for drug administration
- •d) Inborn, or born at site within the recruiting centre’s neonatal network where follow up will be possible
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 810
- •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
- •a) In the opinion of the Principal Investigator, babies unlikely to survive until 48 hours after birth
- •b) Exposure to another macrolide antibiotic
- •c) Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
- •d) Infants born as part of a multiple pregnancy of three or more (i.e. triplets or more)
- •d) Participation in other clinical trials involving other investigational medicinal products
研究者
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已完成
不适用
Azithromycin therapy for chronic lung disease of prematurityISRCTN11650227Cardiff University796