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

尼泊尔南部哺乳期早期均衡能量蛋白补充剂对婴儿生长的影响

基本信息

批准号：
10706521
负责人：
Daniel Joseph Erchick
金额：
$ 56.13万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/10706521
关键词：
Accounting Adult 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 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 Specific qualifier value Supplementation Systems Biology Testing Variant Weight Weight Gain Woman Work World Health Organization adverse birth outcomes adverse pregnancy outcome antenatal care design dietary supplements efficacy testing energy balance evidence base experience feeding follow-up fortification 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

项目摘要

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。