Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial

IF 6.5 1区医学 Q1 NUTRITION & DIETETICS American Journal of Clinical Nutrition Pub Date : 2024-09-01 DOI:10.1016/j.ajcnut.2024.06.008

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Abstract

Background

Maternal undernutrition is a direct risk factor for infant growth faltering.

Objectives

We evaluated the effect of postnatal balanced energy protein (BEP) supplementation in lactating women and azithromycin (AZ) in infants on infant growth outcomes.

Methods

A randomized controlled superiority trial of lactating mother–newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of <23 cm and live infants between 0 and 6 d of life were randomly assigned to 1 of 3 arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization, and health promotion plus iron-folate supplementation until the infant was 6 mo old. In intervention arm 1, mothers additionally received two 75-g sachets of BEP per day. In intervention arm 2, along with the standard-of-care and BEP to the mother, the infant also received 1 dose of azithromycin (20 mg/kg) at the age of 42 d . The primary outcome was infant length velocity at 6 mo. The total sample size was 957 (319 in each arm).

Results

From 1 August, 2018 to 19 May, 2020, 319 lactating mother–newborn dyads were randomly assigned in each arm, and the last follow-up was completed on 20 November, 2020. The mean difference in length velocity (cm/mo) between BEP alone and control was 0.01 (95% confidence interval [CI]: −0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI: 0.03, 0.13), and between BEP + AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) nonfatal events (injectable treatment and/or hospitalizations) were recorded.

Conclusions

Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 mo, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.

This trial was registered at clinicaltrials.gov as NCT03564652.

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母体产后补充均衡能量蛋白和婴儿服用阿奇霉素对婴儿生长结果的影响--一项开放标签随机对照试验。

背景：母亲营养不良是婴儿发育迟缓的直接风险因素：母亲营养不良是婴儿生长迟缓的直接风险因素：我们评估了哺乳期妇女产后补充均衡能量蛋白（BEP）和婴儿服用阿奇霉素（AZ）对婴儿生长结果的影响：设计：在巴基斯坦卡拉奇进行了一项针对哺乳期母亲-新生儿二人组的随机对照优效试验。将打算用母乳喂养中上臂围小于 23 厘米的新生儿和出生后 0-6 天的活产婴儿的母亲按 1:1:1 的比例随机分配到三组中的一组。对照组的哺乳期母亲接受纯母乳喂养、营养、婴儿免疫接种和健康宣传方面的标准护理咨询，并在婴儿满 6 个月前补充铁-叶酸。在干预组 1 中，母亲每天额外服用两袋 75 克的 BEP，而在干预组 2 中，除了标准护理和 BEP 外，婴儿在出生 42 天时还服用了一剂阿奇霉素（每公斤 20 毫克）。主要结果是婴儿 6 个月时的身长速度。总样本量为 957 个（每组 319 个）：从 2018 年 8 月 1 日到 2020 年 5 月 19 日，每组有 319 个哺乳母亲-新生儿二人组被随机分组，最后一次随访于 2020 年 11 月 20 日完成。单用BEP与对照组的身长速度（厘米/月）平均差异为0.01（95% CI：-0.03，0.06），BEP+AZ与对照组的身长速度平均差异为0.08（95% CI：0.03，0.13），BEP+AZ与单用BEP的身长速度平均差异为0.06（95% CI：0.01，0.11）。试验中婴儿死亡人数为1.46%（14/957），非致命事件（注射治疗和/或住院）为17.9%（171/957）：临床试验数据：本试验于2018年6月21日在ClinicalTrials.gov NCT03564652上注册。

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来源期刊

American Journal of Clinical Nutrition 医学-营养学

CiteScore

12.40

自引率

4.20%

发文量

332

审稿时长

38 days

期刊介绍： American Journal of Clinical Nutrition is recognized as the most highly rated peer-reviewed, primary research journal in nutrition and dietetics.It focuses on publishing the latest research on various topics in nutrition, including but not limited to obesity, vitamins and minerals, nutrition and disease, and energy metabolism. Purpose: The purpose of AJCN is to: Publish original research studies relevant to human and clinical nutrition. Consider well-controlled clinical studies describing scientific mechanisms, efficacy, and safety of dietary interventions in the context of disease prevention or health benefits. Encourage public health and epidemiologic studies relevant to human nutrition. Promote innovative investigations of nutritional questions employing epigenetic, genomic, proteomic, and metabolomic approaches. Include solicited editorials, book reviews, solicited or unsolicited review articles, invited controversy position papers, and letters to the Editor related to prior AJCN articles. Peer Review Process: All submitted material with scientific content undergoes peer review by the Editors or their designees before acceptance for publication.