A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants

Cardiff University0 个研究点目标入组 796 人开始时间: 2018年7月31日最近更新: 2024年6月3日

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33028566/ (added 13/08/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38679042/ (added 22/05/2024)

•1. Gestational age =29w+6d (including infants born as one of a multiple birth)
•2. 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)
•3. Presence of an indwelling intravenous line for drug administration
•4. Written informed consent within 72 hours of birth
•5. Anticipating administration of first dose within 72 hours
•6. Reasonable to expect completion of 10 days of trial treatment whilst resident at the recruiting site
•7. Inborn, or born at site within the recruiting site’s neonatal network where follow up will be possible

•1. In the opinion of the Principal Investigator (PI), babies unlikely to survive until 48 hours after birth
•2. Exposure to another systemic macrolide antibiotic (not maternal)
•3. Presence of major surgical or congenital abnormalities (not including patent ductus arteriosus or patent foramen ovale)
•4. Known contraindication of azithromycin as specified in the summary of characteristics of the product
•5. Participation in other interventional trials that precludes participation in AZTEC

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