Workneh Firehiwot, Chin Theresa I, Yibeltal Kalkidan, Fasil Nebiyou, North Krysten, Jensen Sarah K G, Kidane Workagegnhu Tarekegn, Melese Mulatu, Tsegaye Sitota, Berhane Yoseph Yemane, Roy Paladhi Unmesha, Abate Betelhem Haimanot, Teklehaimanot Atsede, Melka Tizita Lemma, Pihl Stephen, An Winko W, Van Dyk Fred, Mullany Luke C, Folger Lian V, Cherkerzian Sara, Troller-Renfree Sonya V, Thomason Moriah E, Andersson Maria, Inder Terrie, Nelson Charles A, Grant P Ellen, Christian Parul, Worku Alemayehu, Berhane Yemane, Lee Anne Cc
Department of Epidemiology and Biostatistics, Addis Continental Institute of Public Health, Addis Ababa, Ethiopia.
Department of Pediatrics, Brigham and Women's Hospital, Boston, Massachusetts, USA
BMJ Paediatr Open. 2024 Dec 24;8(1):e002840. doi: 10.1136/bmjpo-2024-002840.
Maternal undernutrition and inflammation in utero may significantly impact the neurodevelopmental potential of offspring. However, few studies have investigated the effects of pregnancy interventions on long-term child growth and development. This study will examine the effects of prenatal nutrition and infection management interventions on long-term growth and neurodevelopmental outcomes of offspring.
The Enhancing Nutrition and Antenatal Infection Treatment ('ENAT') study (ISRCTN15116516) was a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. The study enrolled 2399 pregnant women who were randomised to receive routine care, an enhanced nutrition package (iron and folic acid, monthly household supply of iodised salt, and micronutrient-fortified balanced energy protein supplement for undernourished women), an enhanced infection management package (genitourinary tract infection screening and treatment, and enhanced deworming), or both packages. In the present Longitudinal Infant Development and Growth study, a subset of 480 children of mothers from ENAT will be recruited equally from each of the four study arms and visited at 12, 18, and 24 months of postnatal age. We will evaluate a range of domains and deploy multiple measures to assess child neurodevelopment, including resting electroencephalography and visual evoked potentials, Hammersmith Infant Neurological Examination, eye-tracking, Bayley Scales of Infant and Toddler Development (Bayley-III), and Magnetic Resonance Imaging (MRI).
This study will advance understanding of the impact of nutrition and inflammation in pregnancy on long-term offspring neurodevelopment. This study aims to fill a critical knowledge gap on the benefits of prenatal interventions to promote the health of mothers and their offspring.
This study was 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 local and international stakeholders.
NCT06296238.
孕期母亲营养不良和炎症可能会对后代的神经发育潜力产生重大影响。然而，很少有研究调查孕期干预对儿童长期生长发育的影响。本研究将探讨产前营养和感染管理干预对后代长期生长和神经发育结局的影响。
“增强营养与产前感染治疗”（'ENAT'）研究（ISRCTN15116516）是一项务实、开放标签、2×2析因、随机临床有效性研究，在埃塞俄比亚阿姆哈拉的12个农村卫生中心开展。该研究招募了2399名孕妇，她们被随机分配接受常规护理、强化营养套餐（铁和叶酸、每月家庭供应碘盐，以及为营养不良妇女提供的微量营养素强化平衡能量蛋白质补充剂）、强化感染管理套餐（泌尿生殖道感染筛查和治疗，以及强化驱虫），或两者兼而有之。在目前的纵向婴儿发育与生长研究中，将从ENAT研究的四个研究组中各平等招募480名母亲的孩子，并在出生后12、18和24个月进行访视。我们将评估一系列领域，并采用多种测量方法来评估儿童神经发育，包括静息脑电图和视觉诱发电位、哈默史密斯婴儿神经学检查、眼动追踪、贝利婴幼儿发育量表（贝利-III），以及磁共振成像（MRI）。
本研究将推进对孕期营养和炎症对后代长期神经发育影响的理解。本研究旨在填补关于产前干预对促进母亲及其后代健康益处的关键知识空白。
本研究获得了亚的斯亚贝巴泛非公共卫生研究所（ACIPH/IRB/002/2022）和布莱根妇女医院（2023P000461）机构审查委员会的批准。研究结果将传播给当地和国际利益相关者。
NCT06296238。
