The Global Network and Preconception Maternal Nutrition

全球网络和孕前孕产妇营养

• 批准号: 8519715
• 负责人: K MICHAEL HAMBIDGE
• 金额: $ 68.42万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8519715
• 关键词: Address; Age; Algorithms; Anthropometry; Awareness; Birth Weight; Blood; Child; Child Mortality; Child health care; Childhood; Collaborations; Colorado; Commit; Communicable Diseases; Communities; Conceptions; Country; Data; Development; Dietary Intervention; Early Intervention; Enrollment; Failure; Female; Folate; Food; Future; Goals; Growth; Guatemala; Guatemalan; Health; Health Benefit; Health Personnel; Health Policy; Incidence; Infant; Intervention; Iron; Leadership; Length; Link; Lipids; Low Birth Weight Infant; Low income; Mentors; Micronutrients; Mission; Morbidity - disease rate; Mothers; Neonatal; Outcome; Perinatal mortality demographics; Placenta; Population; Postpartum Period; Pregnancy; Prevention; Principal Investigator; Proteins; Protocols documentation; Public Health; Randomized; Registries; Research; Research Design; Research Methodology; Resources; Role; Sampling; Second Pregnancy Trimester; Severities; Site; Testing; Training; Ultrasonography; Umbilical Cord Blood; Universities; Weight Gain; Woman; arm; base; data registry; design; efficacy trial; empowered; evidence base; fetal; human capital; inclusion criteria; induced pluripotent stem cell; infancy; intergenerational; mortality; mother nutrition; nutrition; offspring; postnatal; prenatal; primary outcome; public health relevance; randomized trial; reproductive; secondary outcome

DESCRIPTION (provided by applicant): Broad Goal: To participate in all collaborative activities relevant to the mission of the Global Network including the development and leadership of Common Network projects as exemplified by Preconception Maternal Nutrition. Study Objective: Determine the public health benefits in resource-poor populations of providing a comprehensive nutrition supplement to women of reproductive age commencing S3 mo. prior to conception (Arm 1, PC) in comparison with starting the same supplement at 12 wk. gestation (Arm 2, PG) or provision of iron/folate alone (Arm 3, IPS). Primary outcomes: (1) length-for-age Z-score (LAZ) at 7 d postpartum; (2) LAZ at 6 mo. of age. Secondary outcomes include: comparing arms for fetal length; birth weight; incidence of low birth weight; incidence of perinata and early infancy (<6 mo.) mortality and severe infectious disease morbidity. Research Design & Methods: Multi-site randomized controlled efficacy trial. Each arm will include 800 women divided equally among sites. The first 100 of each arm in each site to conceive continue interventions <6 mo. postpartum. Inclusion criteria: para 1-2, <26 yr., enrolled through Global Network Maternal Neonatal Health Registry (MNHR); algorithms based on MNHR data to enroll at 12 ¿ 3 mo. post-partum. Arm 1 commences intervention at enrollment; Arms 2 and 3 receive IPS from enrollment with Arm 2 switching to same supplement as Arm 1 at 12 weeks gestation. Intervention provides 100 kcal/d as a lipid-based multi-micronutrient (MMN) product, with increasing energy to 500 kcal/d and protein to 25g/d if BMI <20 or pregnancy weight gain is low. Baseline parental, fetal (ultrasound), birth weight, early neonatal (7 d) and infant anthropometry (3 and 6 mo.); longitudinal maternal blood, subsample cord blood & placenta samples will be collected by trained Network and Health personnel. Mortality and morbidity data will be collected from MNHR. The primary analyses will compare LAZ at 7 days for Arm 1 vs. Arms 2 and 3 controlling for site. The results of this study have potentially profound implications for the impat of nutrition interventions initiated prior to conception, and for the reversibility of adverse intergenerational effects, including linear growth failure.

描述（由申请人提供）：总体目标：参与与全球网络使命相关的所有合作活动，包括开发和领导共同网络项目，例如孕前孕产妇营养。研究目的：确定在资源贫乏人群中，从受孕前3个月开始向育龄妇女提供全面营养补充剂与在12周开始提供相同营养补充剂的公共卫生效益。妊娠期（组2，PG）或单独提供铁/叶酸（组3，IPS）。主要结局：(1)产后7 d长度年龄Z-score (LAZ)；(2) 6岁的LAZ。次要结局包括：比较双臂胎儿长度；出生体重;低出生体重发生率；围产期和婴儿期（<6个月）死亡率和严重传染病发病率。研究设计与方法：多地点随机对照疗效试验。每个部门将包括800名妇女，在各个地点平均分配。前100名在每个受孕部位的每个手臂继续干预<产后6个月。纳入标准：第1-2段，<26岁，通过全球孕产妇新生儿健康登记网络（MNHR）登记；基于MNHR数据的算法，在产后12点30分登记。第一组在入组时开始干预；第2组和第3组从入组开始接受IPS，第2组在妊娠12周时切换到与第1组相同的补充剂。干预提供100千卡/天的基于脂质的多种微量营养素（MMN）产品，如果BMI <20或妊娠体重增加较低，则能量增加至500千卡/天，蛋白质增加至25克/天。基线父母、胎儿（超声）、出生体重、新生儿早期（7天）和婴儿人体测量（3和6个月）；经培训的网络和卫生人员将采集纵向母体血液、脐带血亚样本和胎盘样本。死亡率和发病率数据将从MNHR收集。初步分析将比较第1组与第2组和第3组7天的LAZ。这项研究的结果对孕前营养干预的影响以及不良代际效应的可逆性（包括线性生长衰竭）具有潜在的深远意义。