Department of Pediatric Newborn Medicine, Global Advancement of Infants and Mothers, Brigham and Women's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA.
BMJ Paediatr Open. 2022 Jan;6(1). doi: 10.1136/bmjpo-2021-001327.
The WHO Nutrition Target aims to reduce the global prevalence of low birth weight by 30% by the year 2025. The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study will test the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management on birth outcomes in rural Ethiopia.
ENAT is a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. Eligible pregnant women presenting at antenatal care (ANC) visits at <24 weeks gestation are enrolled (n=2400). ANC quality is strengthened across all centres. Health centres are randomised to receive an enhanced nutrition package (ENP) or standard nutrition care, and within each health centre, individual women are randomised to receive an enhanced infection management package (EIMP) or standard infection care. At ENP centres, women receive a regular supply of adequately iodised salt and iron-folate (IFA), enhanced nutrition counselling and those with mid-upper arm circumference of <23 cm receive a micronutrient fortified balanced energy protein supplement (corn soya blend) until delivery. In standard nutrition centres, women receive routine counselling and IFA. EIMP women have additional screening/treatment for urinary and sexual/reproductive tract infections and intensive deworming. Non-EIMP women are managed syndromically per Ministry of Health Guidelines. Participants are followed until 1-month post partum, and a subset until 6 months. The primary study outcomes are newborn weight and length measured at <72 hours of age. Secondary outcomes include preterm birth, low birth weight and stillbirth rates; newborn head circumference; infant weight and length for age z-scores at birth; maternal anaemia; and weight gain during pregnancy.
ENAT is approved by the Institutional Review Boards of Addis Continental Institute of Public Health (001-A1-2019) and Mass General Brigham (2018P002479). Results will be disseminated to local and international stakeholders.
ISRCTN15116516.
世界卫生组织营养目标旨在到 2025 年将全球低出生体重的发生率降低 30%。增强营养和产前感染治疗（ENAT）研究将测试一揽子妊娠干预措施对改善孕产妇营养和感染管理对埃塞俄比亚农村出生结局的影响。
ENAT 是一项在埃塞俄比亚阿姆哈拉的 12 个农村卫生中心实施的实用、开放性、2×2 析因、随机临床有效性研究。在<24 周妊娠的产前保健（ANC）就诊时，合格的孕妇被纳入（n=2400）。所有中心都加强了 ANC 质量。卫生中心被随机分配接受强化营养包（ENP）或标准营养护理，在每个卫生中心内，个体妇女被随机分配接受强化感染管理包（EIMP）或标准感染护理。在 ENP 中心，妇女定期获得充足碘盐和铁叶酸（IFA），接受强化营养咨询，中上臂围<23cm 的妇女在分娩前接受强化营养咨询和富含微量营养素的平衡能量蛋白质补充剂（玉米大豆混合物）。在标准营养中心，妇女接受常规咨询和 IFA。EIMP 妇女有额外的筛查/治疗尿路和性/生殖感染，并进行强化驱虫。非 EIMP 妇女根据卫生部指南进行综合管理。参与者一直随访到产后 1 个月，部分参与者随访到 6 个月。主要研究结局是出生后<72 小时新生儿体重和身长。次要结局包括早产、低出生体重和死产率；新生儿头围；出生时婴儿体重和身长的年龄 z 评分；产妇贫血；以及怀孕期间体重增加。
ENAT 得到了亚的斯亚贝巴大陆公共卫生研究所的机构审查委员会（001-A1-2019）和马萨诸塞州综合医院的批准（2018P002479）。结果将传播给当地和国际利益相关者。
ISRCTN84036354。
