The Global Network and Preconception Maternal Nutrition

描述（由申请人提供）：广泛的目标：参加与全球网络的使命相关的所有合作活动，包括共同网络项目的开发和领导，如孕前孕产妇营养。研究目的：确定从S3月开始向育龄妇女提供全面营养补充剂对资源贫乏人群的公共卫生益处。在怀孕前（组1，PC）相比，在12周开始相同的补充。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时的年龄别身长Z评分（LAZ）;（2）6 mo时的LAZ。年龄。次要结局包括：比较两组的胎儿长度;出生体重;低出生体重的发生率;围产期和早期婴儿（<6个月）的发生率。死亡率和严重传染病发病率。研究设计与方法：多中心随机对照疗效试验。每组将包括800名妇女，平均分配到各个研究中心。每个研究中心每组的前100名怀孕者继续干预<6个月。产后入选标准：第1-2段，<26岁，通过全球网络孕产妇新生儿健康登记处（MNHR）入组;算法基于MNHR数据，在12 - 3个月时入组。产后组1在入组时开始干预;组2和组3从入组时接受IPS，组2在妊娠12周时转换为与组1相同的补充剂。干预措施提供100千卡/天作为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，则将能量增加到500千卡/天，蛋白质增加到25克/天。基线父母、胎儿（超声）、出生体重、早期新生儿（7天）和婴儿人体测量（3和6个月）;纵向母体血液、子样本脐带血和胎盘样本将由经过培训的网络和卫生人员采集。将从MNHR收集死亡率和发病率数据。主要分析将比较第1组与第2组和第3组在第7天的LAZ，以控制研究中心。本研究的结果对受孕前开始的营养干预的影响以及代际不良影响（包括线性生长失败）的可逆性可能具有深远的影响。

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.