The Global Network and Preconception Maternal Nutrition

全球网络和孕前孕产妇营养

• 批准号: 9269583
• 负责人: NANCY F KREBS
• 金额: $ 121.62万
• 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 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9269583
• 关键词: Address; Age; Algorithms; Anthropometry; Awareness; Birth Weight; Blood; Child; Child Mortality; Child health care; Collaborations; Colorado; Communicable Diseases; Communities; Conceptions; Country; Data; Development; Dietary Intervention; Early Intervention; Enrollment; Failure; Female; Folic Acid; Food; Future; Goals; Growth; Guatemala; Guatemalan; Health; Health Benefit; Health Personnel; Health Policy; Incidence; Individual; Infant; Institution; Intervention; Iron; Leadership; Length; Link; Lipids; Low Birth Weight Infant; Mentors; Micronutrients; Mission; Morbidity - disease rate; Mothers; Neonatal; Outcome; Perinatal mortality demographics; Placenta; Population; Postpartum Period; Pregnancy; Prevention; 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; delta protein; design; early childhood; efficacy trial; empowered; evidence base; fetal; human capital; inclusion criteria; infancy; intergenerational; low income country; 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（由适用提供）：广泛的目标：参与与全球网络的使命相关的所有协作活动，包括在孕妇孕妇营养前举例说明的通用网络项目的发展和领导。研究目标：确定资源贫乏人群的公共卫生益处，以向赞扬S3 MO的生殖年龄妇女提供全面的营养补充。在概念之前（ARM 1，PC）与在12周开始相同的补充剂相比。妊娠（ARM 2，PG）或单独提供铁/叶酸（ARM 3，IPS）。主要结果：（1）产后7 d时长的Z分数（LAZ）； （2）LAZ在6 mo。年龄。次要结果包括：比较胎儿长度的手臂；出生体重；低出生体重的发生率；佩里纳塔和婴儿早期（<6 mo。）死亡率和严重感染发病率的发病率。研究设计与方法：多站点随机对照效率试验。每个手臂将包括800名妇女在站点之间平均分配。每个部位中的每个臂的前100个以构想继续进行干预措施<6 mo。产后。纳入标准：第1-2段，<26年，通过全球网络母体新生儿健康注册中心（MNHR）招募；基于MNHR数据的算法在12 mo中注册。产后。 ARM 1开始入学时干预；武器2和3从入学中接收IP，ARM 2在妊娠12周时切换到与ARM 1相同的补充剂。干预提供100 kcal/d作为基于脂质的多微晶（MMN）产品，如果BMI <20或怀孕体重增加较低，则能量增加到500 kcal/d，蛋白质为25g/d。基线父母，胎儿（超声），出生体重，早期新生儿（7 d）和婴儿人体测量法（3和6 mo。）；纵向的物物血液，脐带血和斑点样品将由训练有素的网络和卫生人员收集。死亡率和发病率数据将从MNHR收集。主要分析将比较第7天的LAZ，而ARM 1 vs. ARM 2和3控制位点的LAZ。这项研究的结果对在受孕之前开始的营养干预措施以及不良代际效应（包括线性生长失败）的可逆性具有潜在的深远影响。