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 低水平收入国家（LMIC）中营养不良的妇女经历了更大的胎儿生长限制 在怀孕和较差的出生结果中，包括早产和小胎龄（SGA）。婴儿 天生的早产和/或SGA更容易受到发育迟缓和神经认知发展不足的影响， 成年后的持久影响。针对怀孕和泌乳的营养干预措施具有 破坏营养不良的代际周期的潜力。最近，一项专家共识达到了 强化BEP的“现成”食品补充剂的规格 这需要在营养不足的设置中进行测试，以提高出生和成长结果的效率。 目前，没有建议为母乳喂养的女性补充，dospite高 LMIC的早期生命的伪造率，遗产不足和排他性 建议母乳喂养。我们的研究目的是1）评估每日BEP ++在怀孕中的影响 和/或哺乳对婴儿的生长结果的泌乳； 2）评估每日BEP ++在 怀孕和/或哺乳性孕产妇营养状况并探索婴儿的潜在调解途径 增长结果； 3）在生物测量子研究中，探索母子与婴儿之间的关系 养分状态，注射，人奶成分和肠道微生物组，通过补充怀孕 和/或泌乳与没有。我们提出了每日BEP ++的基于社区的随机对照试验 尼泊尔农村地区哺乳期间的补充（拟议中）。我们的研究人群的比率很高 孕产妇不足，不良出生结果和婴儿的生长不良，并代表农村环境 在南亚。为了进行此试验，我们将利用我们社区基础现场的基础设施和 计划于2022年开始的孕妇BEP ++补充剂的随机试验（父母试验）。这 家长试验将在怀孕中招募孕妇，随机将其补充或没有 补充和随访，直到出生以评估SGA事件。我们建议1）增加产后 使用2x2阶乘设计补充怀孕后的补充试验，以评估 BEP ++补充剂在泌乳期间和测量生命6个月时婴儿的生长结果，2）两倍 入学的孕妇的总体样本大小，可以发现有意义的差异 产后补充，3）在试验中嵌套一个生物镜子研究，以探索目标 母子和婴儿营养状况与婴儿生长之间的因果关系。样本2,000 孕妇将产生1,600名活产和1,440名婴儿，直到6个月（考虑到怀孕 损失和随访）。这将使我们能够检测到我们的主要结果的差异 Z年龄在6个月的评分，在泌乳中的补充剂与无补充之间的Z分数为0.16 Z分数。