Long-lasting effect of oral azithromycin taken by women during labour on infant nutrition: Follow-up cohort of a randomized clinical trial in western Gambia.

OBJECTIVE: To assess the effect of administering an oral dose of 2g of azithromycin in Gambian women during labour on infant growth. METHODS: Children whose mothers had been randomized to receive either an oral dose of 2g of azithromycin or placebo during labour were visited at home at the end of infancy by trained study nurses blind to the treatment allocation. The follow-up visit of these cohorts (exposed and non-exposed to azithromycin), which was not part of the original trial design, was conducted between November 2014 and May 2015 when the infants were 11 to 13 months of age. During visits, nurses recorded anthropometrical measurements and transcribed information from the infants' welfare cards. RESULTS: Four-hundred and sixty-five (79.6%) of the 584 infants aged 11-13 months at the time of the survey were recruited. The proportion of children with an age-adjusted Z-score <-2SD for mid-upper-arm circumference (MUAC) was lower among those exposed to azithromycin [1.3% versus 6.3%, OR = 0.21 95%CI (0.06,0.72), p = 0.006] and there was weak evidence of a difference in the proportion of infants with weight-for-age (WAZ) Z-score <-2SD [7.1% versus 12.1%, OR = 0.58 95%CI (0.33,1.04), p = 0.065]. For all other malnutrition indicators the proportions were similar in the exposed and un-exposed cohort. CONCLUSIONS: Our results show that azithromycin in labour may have a beneficial effect in MUAC among children who are below the curve. Larger studies with closer follow-up are warranted. TRIAL REGISTRATION (MAIN TRIAL): ClinicalTrials.gov Identifier NCT01800942.