EUCTR2018-001109-99-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 - Azithromycin Therapy for Chronic Lung Disease of Prematurity
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 796
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 =29w+6d (including infants born as one of a multiple birth)
- •b)Neonates who have had respiratory support for at least 2 continuous hours duration during the first 72 hours of life (intubated, or by non-invasive mechanical ventilation including continuous positive airway pressure and high flow nasal cannula or a combination thereof)
- •c)Presence of an indwelling intravenous line for drug administration
- •d)Written informed consent within 72 hours of birth at the latest
- •e) Anticipating administration of first dose within 72 hours of birth at the latest
- •f)Reasonable to expect completion of 10 days of trial treatment whilst resident at the recruiting site
- •g)Inborn, or born at site within the recruiting site's neonatal network where follow up will be possible
- •h)In the opinion of the PI, reasonable prospect of survival past the first 72 hours of life
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 796
- •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)Exposure to another systemic macrolide antibiotic (not maternal)
- •b)Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
- •c)Known contraindication of azithromycin as specified in the summary of characteristics of the product
- •d)Participation in other interventional trials that precludes participation in AZTEC
研究者
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已完成
不适用
Azithromycin therapy for chronic lung disease of prematurityISRCTN11650227Cardiff University796