- Design
- Follow-up of a randomised placebo-controlled trial, masked assessors
- Population
- 403 children born at 34 weeks or later with asphyxia, six LMIC sites including two in India
- Primary outcome
- Bayley-III cognitive composite at 24 months corrected age
- Effect
- 90.9 vs 90.9; mean difference 0.29 (95% CI -1.77 to 2.34)
A-PLUS randomised labouring women in six low- and middle-income sites — two of them in India — to a single 2 g oral dose of azithromycin or placebo. This follow-up assessed 403 children born at 34 weeks or later with signs of asphyxia (5-minute Apgar below 7 or needing bag-and-mask ventilation), using masked Bayley-III examiners at 24 months corrected age.
Cognitive composite scores were identical (90.9 in both arms; mean difference 0.29, 95% CI -1.77 to 2.34). Language and motor scores, and all five ASQ-3 domains, did not differ, and South Asian and African sites gave the same answer.
The hypothesis was that reducing infection-driven inflammation around birth might protect the asphyxiated brain. This follow-up does not support it. Intrapartum azithromycin should be judged on its maternal infection outcomes, not on any neurodevelopmental promise.
- Do not give intrapartum azithromycin with the aim of protecting the newborn brain
- Newborns with Apgar below 7 at 5 minutes still need structured developmental follow-up, whatever antibiotic the mother received
- The India sites contributed directly, so this answer applies to Indian labour wards
- Any decision about intrapartum azithromycin rests on maternal sepsis outcomes, not child development
Why it matters
It closes off one proposed benefit of a cheap intervention that is being considered for wide use in labour.
The statistics, in plain English
A mean difference of 0.29 points on a scale with a standard deviation of about 11, with an interval from -1.77 to 2.34, rules out any clinically meaningful benefit.
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