Roy Paladhi Unmesha, Workneh Firehiwot, Baye Estifanos, Derebe Mulatu Melese, Yibeltal Kalkidan, Fasil Nebiyou, Driker Sophie, Van Dyk Fred, I Chin Theresa, North Krysten, Jensen Sarah K G, Christian Parul, Worku Alemayehu, Berhane Yemane, Lee Anne C
Brown University Division of Biology and Medicine, Providence, Rhode Island, USA
Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.
BMJ Open. 2025 Apr 28;15(4):e098686. doi: 10.1136/bmjopen-2024-098686.
Maternal undernutrition and infections during pregnancy may influence birth and long-term child development outcomes. Characterising the micronutrient, metabolomic and microbiome profiles of pregnant women and infants may elucidate the underlying biology of adverse birth outcomes and early child development in the first 1000 days.
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study was a 2×2 factorial, randomised clinical effectiveness study conducted in Amhara, Ethiopia from August 2020 to June 2022. We cluster-randomised pregnant women (n=2399) to receive either a nutrition intervention (iron-folic acid (IFA), iodised salt and balanced energy-protein supplementation for women with mid-upper arm circumference <23 cm) or routine care (IFA only), and individually randomised women to an infection control intervention (genitourinary tract infection screening-treatment and screening-treatment of stool parasites) or routine care (syndromic approach). Participants were followed until 1 month postpartum. A subset of 532 women-infant dyads were consecutively enrolled in the biospecimen substudy from July 2021 to August 2022. Specimens were collected at enrolment (<24 weeks) and antenatal care follow-up (third trimester), and 1-6 months postdelivery. A subset of ENAT mother-infant dyads (n=462) was enrolled in the Longitudinal Infant Development and Growth study that followed infants until 24 months postpartum, from February 2023 to June 2024. We will determine the impact of ENAT interventions on micronutrient status, inflammation biomarkers and metabolomic and microbiome profiles. We will also determine the association of these profiles with birth outcomes and infant neurodevelopment.
These studies were approved by the Institutional Review Boards of Addis Continental Institute of Public Health (ACIPH/IRB/002/2022) and Mass General Brigham (2023P000461). Results will be disseminated to international stakeholders via peer-reviewed journals and locally via strategic dissemination sessions.
ISRCTN15116516 and NCT06296238.
孕期母亲营养不良和感染可能会影响分娩及儿童长期发育结局。描绘孕妇和婴儿的微量营养素、代谢组学和微生物组特征，可能会阐明不良分娩结局及儿童早期1000天发育的潜在生物学机制。
强化营养与产前感染治疗（ENAT）研究是一项2×2析因随机临床疗效研究，于2020年8月至2022年6月在埃塞俄比亚阿姆哈拉开展。我们将孕妇（n = 2399）进行整群随机分组，分别接受营养干预（铁叶酸（IFA）、碘盐以及为上臂中段周长<23 cm的女性补充能量-蛋白质平衡制剂）或常规护理（仅IFA），并将女性个体随机分组接受感染控制干预（泌尿生殖道感染筛查-治疗及粪便寄生虫筛查-治疗）或常规护理（症状处理方法）。对参与者进行随访直至产后1个月。2021年7月至2022年8月，连续纳入532对母婴二元组参与生物样本子研究。在入组时（孕<24周）、产前检查随访（孕晚期）以及产后1 - 6个月采集样本。2023年2月至2024年6月，ENAT母婴二元组的一个子集（n = 462）被纳入纵向婴儿发育与生长研究，对婴儿进行随访直至产后24个月。我们将确定ENAT干预对微量营养素状态、炎症生物标志物以及代谢组学和微生物组特征的影响。我们还将确定这些特征与分娩结局和婴儿神经发育之间的关联。
这些研究已获得亚的斯亚贝巴非洲公共卫生研究所（ACIPH/IRB/002/2022）和布莱根妇女医院（2023P000461）机构审查委员会的批准。研究结果将通过同行评审期刊向国际利益相关者传播，并在当地通过战略传播会议进行传播。
ISRCTN15116516和NCT06296238。
