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The problem
Intervention: 52 weeks of azithromycin (a macrolide antibiotic) administered as prophylaxis to prevent lower respiratory tract infections
Who it was tested with: 90 children and young people aged 3-17 years with diagnosed non-progressive, non-neuromuscular neurological impairment (mainly cerebral palsy) and persistent respiratory symptoms at risk of lower respiratory tract infection.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"PARROT was a multicentre, parallel group, blinded, pragmatic randomised controlled trial of 52-week duration" with randomisation to treatment groups and comparison of outcomes between azithromycin and placebo arms. The early closure and resulting underpowering prevents determination of intervention effectiveness, classifying the evidence as inconclusive despite the experimental design.
Trial stopped early due to COVID-19 pandemic with recruitment closure, resulting in underpowered analysis (90 participants instead of planned 500). High attrition rate and substantial missing data for secondary outcomes. Confidence intervals cross the null, preventing definitive conclusions.
Across countries and designs
1 study · 2 countries