Balanced Energy Protein Supplement in Early Lactation on Infant Growth in Southern Nepal

尼泊尔南部哺乳期早期补充均衡能量蛋白对婴儿生长的影响

• 批准号: 10504014
• 负责人: Daniel Joseph Erchick
• 金额: $ 59.79万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10504014
• 关键词: Accounting; Address; Adult; Age; Age-Months; Asia; Biological Specimen Banks; Birth; Breast Feeding; Calcium; Child; Childhood; Collaborations; Communities; Consensus; Detection; Development; Dietary Intervention; Dose; Enrollment; Evidence based intervention; Exclusive Breastfeeding; Fetal Growth Retardation; Food Supplements; France; Future; Growth; Health; Human Milk; Incidence; Infant; Inflammation; Infrastructure; Intervention Trial; Lactation; Length; Life; Link; Lipids; Live Birth; Malnutrition; Measures; Mediation; Mediator of activation protein; Micronutrients; Milk; Morbidity - disease rate; Mothers; Nepal; Neurocognitive; Newborn Infant; Nutrient; Nutritional; Nutritional Study; Nutritional Support; Nutritional status; Outcome; Parents; Pathway interactions; Performance; Policies; Population; Postpartum Period; Pregnancy; Pregnancy loss; Pregnant Women; Premature Birth; Prevalence; Proteins; Randomized; Randomized Controlled Trials; Recommendation; Research; Resource-limited setting; Rural; Sample Size; Sampling; Schedule; Site; Small for Gestational Age Infant; Supplementation; Systems Biology; Testing; Variant; Weight; Weight Gain; Woman; Work; World Health Organization; adverse birth outcomes; adverse pregnancy outcome; antenatal care; base; design; dietary supplements; efficacy testing; evidence base; experience; feeding; follow-up; gut microbiome; high risk infant; improved; infant outcome; intergenerational; low and middle-income countries; mortality risk; mother nutrition; postnatal; pregnant; primary outcome; programs; randomized trial; recruit; rural setting; secondary outcome; study population; treatment arm; wasting

ABSTRACT Undernourished women in low-and-middle income countries (LMICs) experience greater fetal growth restriction in pregnancy and poorer birth outcomes, including preterm birth and small-for-gestational age (SGA). Infants born preterm and/or SGA are more vulnerable to stunting and inadequate neurocognitive development, with lasting effects through adulthood. Nutritional interventions targeted in pregnancy and lactation have the potential to break the intergenerational cycle of malnutrition. Recently, an expert consensus developed specifications for a fortified BEP “ready-to-use” food supplement for pregnant and lactating women in LMICs, which requires testing in undernourished settings for efficacy in improving birth and growth outcomes. Currently, there is no recommendation for supplementation for women who are breastfeeding, despite high rates of growth faltering in early life in LMICs, where maternal undernutrition is high and exclusive breastfeeding is recommended. Our research aims to 1) Evaluate the effect of daily BEP++ in pregnancy and/or lactation on infant growth outcomes in the first 6 months of life; 2) Evaluate the effect of daily BEP++ in pregnancy and/or lactation on maternal nutritional status and explore potential mediation pathways on infant growth outcomes; and 3) In a biospecimen sub-study, explore relationships between maternal and infant nutrient status, inflammation, human milk composition, and gut microbiome by supplementation in pregnancy and/or lactation vs. not. We propose a community-based, randomized controlled trial of daily BEP++ supplementation during lactation in rural Nepal (proposed addition). Our study population has high rates of maternal undernutrition, adverse birth outcomes, and poor infant growth, and is representative of rural settings in South Asia. To conduct this trial, we will leverage the infrastructure of our community-based field site and a randomized trial of a BEP++ supplement in pregnant women scheduled to begin in 2022 (parent trial). The parent trial will recruit pregnant women in pregnancy, randomize them to supplement in pregnancy or no supplement, and follow-up until birth to assess SGA incidence. We propose to 1) add a postpartum supplementation trial following supplementation in pregnancy, using a 2x2 factorial design, to evaluate the BEP++ supplement during lactation and measure infant growth outcomes at 6 months of life, 2) double the overall sample size of pregnant women enrolled to allow for detection of meaningful differences between postpartum supplementation, and 3) nest a biospecimen sub-study within the trial to explore aims on the causal relationships between maternal and infant nutritional status and infant growth. A sample of 2,000 pregnant women will yield 1,600 live births and 1,440 infants followed until 6 months (accounting for pregnancy loss and loss to follow-up). This will allow us to detect a difference for our primary outcome, mean length-for- age Z score at 6 months, between supplement in lactation vs. no supplement, of 0.16 Z scores.

抽象的 中低收入国家 (LMIC) 营养不良的妇女胎儿生长受限更严重 妊娠期和较差的出生结果，包括早产和小于胎龄 (SGA)。婴儿 早产儿和/或 SGA 更容易发育迟缓和神经认知发育不足， 影响整个成年期。针对妊娠期和哺乳期的营养干预措施 打破营养不良代际循环的潜力。近日，专家达成共识 针对中低收入国家孕妇和哺乳期妇女的强化 BEP“即用型”食品补充剂规范， 这需要在营养不良的环境中进行测试，以了解改善出生和生长结果的功效。 目前，尽管母乳喂养的女性摄入量较高，但不建议母乳喂养的女性补充补充剂。 中低收入国家的生命早期生长速度缓慢，孕产妇营养不良程度高且排他性 建议母乳喂养。我们的研究目的是 1) 评估每日 BEP++ 对怀孕的影响 和/或哺乳对婴儿出生后 6 个月内生长结果的影响； 2) 评估每日 BEP++ 的效果 妊娠和/或哺乳期对母亲营养状况的影响，并探索对婴儿的潜在调节途径 增长成果； 3) 在生物样本子研究中，探索母婴之间的关系 怀孕期间补充营养状况、炎症、母乳成分和肠道微生物组 和/或哺乳期与非哺乳期。我们提出一项基于社区的每日 BEP++ 随机对照试验 尼泊尔农村地区哺乳期的补充（建议添加）。我们的研究人群有很高的比例 孕产妇营养不良、出生结果不良和婴儿生长不良，并且是农村地区的代表 在南亚。为了进行这项试验，我们将利用基于社区的现场站点的基础设施和 计划于 2022 年开始在孕妇中进行 BEP++ 补充剂的随机试验（母试验）。这 家长试验将招募怀孕期间的孕妇，随机分组她们在怀孕期间补充或不补充 补充，并随访直至出生，以评估 SGA 发生率。我们建议 1) 添加产后 妊娠期补充后的补充试验，使用 2x2 析因设计，以评估 BEP++ 在哺乳期间补充，并在 6 个月大时测量婴儿生长结果，2) 双倍 纳入孕妇的总体样本量，以便检测孕妇之间有意义的差异 产后补充，3) 在试验中进行生物样本子研究，以探索以下目标： 母婴营养状况与婴儿生长之间的因果关系。 2,000个样本 孕妇将产下 1,600 名活产婴儿，并在 6 个月内产下 1,440 名婴儿（考虑到怀孕 损失和后续损失）。这将使我们能够检测到主要结果的差异，即平均长度- 6 个月时的年龄 Z 评分（哺乳期补充剂与不补充剂之间的 Z 评分为 0.16）。