The Global Network and Preconception Maternal Nutrition

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，包括共同网络项目的开发和领导，以孕前孕产妇营养为例。研究目的：确定从第 3 个月开始向育龄妇女提供全面营养补充剂对资源匮乏人群的公共健康益处。受孕前（第 1 组，PC）与第 12 周开始使用相同补充剂进行比较。妊娠（第 2 组，PG）或单独提供铁/叶酸（第 3 组，IPS）。主要结局：（1）产后 7 天的年龄别身长 Z 评分（LAZ）； (2) 6 个月时的 LAZ。的年龄。次要结果包括：比较胎儿的手臂长度；出生体重；低出生体重的发生率；围产期和婴儿早期（<6 个月）死亡率和严重传染病发病率的发生率。研究设计和方法：多中心随机对照疗效试验。每个部门将包括 800 名女性，平均分配到各个地点。每个地点每组的前 100 名受孕者继续干预 <6 个月。产后。纳入标准：第 1-2 段，<26 岁，通过全球网络孕产妇新生儿健康登记处 (MNHR) 登记；基于 MNHR 数据的算法在 12 ¿ 3 个月注册。产后。第 1 组在入组时开始干预；第 2 组和第 3 组在注册时接受 IPS，第 2 组在妊娠 12 周时切换为与第 1 组相同的补充剂。干预措施提供 100 kcal/d 的脂质多微量营养素 (MMN) 产品，如果 BMI <20 或妊娠体重增加较低，则将能量增加至 500 kcal/d，将蛋白质增加至 25g/d。父母基线、胎儿（超声）、出生体重、早期新生儿（7 天）和婴儿人体测量（3 个月和 6 个月）；纵向母血、脐带血子样本和胎盘样本将由经过培训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 1 组与第 2 组和第 3 组在 7 天时的 LAZ 控制位点。这项研究的结果对于受孕前开始的营养干预措施的影响以及不良代际效应（包括线性生长障碍）的可逆性具有潜在的深远影响。

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.