母亲产后均衡能量蛋白质补充和婴儿阿奇霉素对婴儿生长结局的影响：一项开放标签随机对照试验。
Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial.
机构信息
Vaccines and Other Initiatives to Advance Lives (VITAL) Pakistan Trust, Karachi, Pakistan.
Center of Excellence for Trauma and Emergencies and Community Health Sciences, The Aga Khan University, Karachi, Pakistan; Global Advancement of Infants and Mothers (AIM), Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Harvard T. H. Chan School of Public Health, Boston, MA, United States; Center for Research and Training in Disaster Medicine, Humanitarian Aid and Global Health (CRIMEDIM), Università degli Studi del Piemonte Orientale "Amedeo Avogadro," Vercelli, Italy.
出版信息
Am J Clin Nutr. 2024 Sep;120(3):550-559. doi: 10.1016/j.ajcnut.2024.06.008. Epub 2024 Jun 24.
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.
背景
母体营养不足是婴儿生长迟缓的直接危险因素。
目的
我们评估了哺乳期妇女补充产后平衡能量蛋白（BEP）和婴儿阿奇霉素（AZ）对婴儿生长结果的影响。
方法
这是一项在巴基斯坦卡拉奇进行的、针对哺乳期母婴二人组的随机对照优效性试验。研究纳入的母亲计划用母乳喂养其出生后 6 天内、中上臂围＜23cm 的婴儿，随机按 1:1:1 的比例分配到 3 个组。对照组的哺乳期母亲接受关于纯母乳喂养、营养、婴儿免疫接种和健康促进以及铁叶酸补充的标准护理咨询，直至婴儿 6 个月大。干预组 1 的母亲每天另外接受两袋 75g 的 BEP。干预组 2 中，除了标准护理和 BEP 给母亲外，婴儿在 42 天时还接受一剂 AZ（20mg/kg）。主要结局是婴儿在 6 个月时的身长增长速度。总样本量为 957 例（每组 319 例）。
结果
从 2018 年 8 月 1 日至 2020 年 5 月 19 日，每组 319 例哺乳期母婴二人组随机分组，最后一次随访于 2020 年 11 月 20 日完成。BEP 组与对照组之间的平均身长增长速度差异为 0.01cm/月（95%置信区间：-0.03，0.06），BEP+AZ 组与对照组之间的差异为 0.08cm/月（95%置信区间：0.03，0.13），BEP+AZ 组与 BEP 组之间的差异为 0.06cm/月（95%置信区间：0.01，0.11）。试验中有 1.46%（14/957）的婴儿死亡，17.9%（171/957）发生非致死性事件（注射治疗和/或住院）。
结论
产后母亲补充 BEP 和婴儿使用 AZ 可以适度改善婴儿 6 个月时的生长结果，这表明同时解决母婴营养不足可能具有潜在益处。本试验在 clinicaltrials.gov 注册，编号为 NCT03564652。
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