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

ObjectiveTo assess the effect of administering an oral dose of 2g of azithromycin in Gambian women during labour on infant growth.MethodsChildren 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.ResultsFour-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 ConclusionsOur 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.

**研究目的**：评估冈比亚产妇于分娩期间单次口服2g阿奇霉素对其所生婴儿生长发育的影响。
**研究方法**：本研究对分娩期间被随机分配口服2g阿奇霉素或安慰剂的产妇所诞下的婴儿，于婴儿期结束后由经过统一培训且对治疗分配方案设盲的研究护士开展家庭随访。此项未纳入原始试验设计的队列（阿奇霉素暴露组与非暴露组）随访工作，于2014年11月至2015年5月期间实施，此时受试婴儿年龄为11至13月龄。随访过程中，护士记录婴儿的人体测量学指标，并抄录婴儿保健卡中的相关信息。
**研究结果**：本次调研共纳入584名11~13月龄婴儿中的465名，纳入率为79.6%。经年龄校正的Z评分儿童占比[原文此处内容缺失]
**研究结论**：本研究结果表明，产妇分娩期间使用阿奇霉素或可对低于生长曲线的儿童的中上臂围（Mid-Upper Arm Circumference, MUAC）产生有益影响。后续需开展样本量更大、随访更为紧密的研究以验证该结论。
**试验注册**：主试验临床注册号为ClinicalTrials.gov标识符NCT01800942。