MRC Unit at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS One. 2018 Oct 25;13(10):e0206348. doi: 10.1371/journal.pone.0206348. eCollection 2018.
To assess the effect of administering an oral dose of 2g of azithromycin in Gambian women during labour on infant growth.
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.
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.
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.
评估在冈比亚妇女分娩时口服 2 克阿奇霉素对婴儿生长的影响。
接受随机分配接受 2 克阿奇霉素或安慰剂的母亲的儿童，在婴儿出生后由经过培训的研究护士在家中进行随访，这些护士对治疗分配情况不知情。这些队列（暴露和未暴露于阿奇霉素）的随访是原始试验设计的一部分，在 2014 年 11 月至 2015 年 5 月之间进行，当时婴儿年龄在 11 至 13 个月之间。在访问期间，护士记录了体格测量值并转录了婴儿福利卡上的信息。
在调查时年龄在 11-13 个月的 584 名婴儿中，有 465 名（79.6％）被招募。接受阿奇霉素治疗的儿童中，年龄调整后的上臂中部周长（MUAC）Z 分数<-2SD 的儿童比例较低[1.3％对 6.3％，OR = 0.21 95％CI（0.06,0.72），p = 0.006]，而体重年龄（WAZ）Z 分数<-2SD 的婴儿比例有微弱的差异[7.1％对 12.1％，OR = 0.58 95％CI（0.33,1.04），p = 0.065]。对于所有其他营养不良指标，暴露组和未暴露组的比例相似。
我们的结果表明，分娩时使用阿奇霉素可能对 MUAC 低于曲线的儿童有有益的影响。需要进行更大规模的研究，并进行更密切的随访。
临床试验（主要试验）注册：ClinicalTrials.gov 标识符 NCT01800942。
