Zn & Maternal-Infant Brain Function in S. Ethiopia: Randomized Controlled Trials

描述（由申请人提供）：本研究计划的广泛目标是确定通过预防/治疗粮食不安全高风险人群的营养不良可以实现的母婴脑功能和发育的益处。该提案的具体目的是确定母亲和婴儿补充锌（Zn）对母婴认知、气质和结合以及对产前和产后大脑发育的影响。该提案包括进一步开发尼加拉瓜大学的研究资源。研究设计是一项随机对照试验（RCT），从妊娠早期至哺乳期9个月，母亲补充3种不同剂量的锌（0、12.5和25 mg/d），并在此基础上，对6-9个月婴儿补充低剂量锌（0或3 mg/d）。这项研究将包括埃塞俄比亚南部五个邻近的西达玛农村社区的900名妇女及其子女。所有的母亲将每天接受多种维生素和能量蛋白质补充剂。将在基线、妊娠24 <$2和34 <$2周以及哺乳6和9个月时，通过Raven's彩色渐进矩阵和Kaufman-ABC在社区环境中纵向评估母体认知。产后抑郁症将通过爱丁堡产后抑郁量表进行评估，母婴互动通过护理儿童评估-喂养和教学量表（NCAST）进行评估。在6岁（补充前）和9个月时，将通过新奇偏好评估婴儿神经认知发育;通过实验室气质评估组合+Bayley行为记录评估气质;通过Bayley PDI评估运动功能。婴儿头围、体重和身长将在分娩后3天测量，然后每月测量一次。次要结局指标为：传染病发病率发病率;产前和产后生长;孕妇血浆和母乳中的锌浓度以及锌吸收量。将使用一系列统计分析来检查第1项RCT（3组单向设计）和第2项RCT（2x 3析因）的效应，双侧显著性为p=0.05。提高对锌的作用的理解是必不可少的，全面了解营养不良对母婴脑功能和发育的影响，因此，制定最佳的公共卫生战略，预防营养相关的脑功能障碍。

DESCRIPTION (provided by applicant): The broad objective of this research program is to determine the benefits for maternal-young child brain function and development that can be achieved by preventing/treating malnutrition in a population at high risk from food insecurity. The specific aims of this proposal are to determine the effects of maternal and infant zinc (Zn) supplementation on: maternal-infant cognition, temperament and bonding and on pre-and post-natal brain growth. The proposal includes further development of research resources at Debub University. The research design is a randomized controlled trial (RCT) of 3 different doses (0,12.5 and 25mg Zn/d) of maternal Zn supplementation from early 2nd trimester of pregnancy until 9 months lactation and, nested within this, a second RCT of a low dose of Zn (0 or 3 mg Zn/d) administered to their infants from age 6-9 months. The study will include 900 women and their offspring in five adjacent rural Sidama communities in southern Ethiopia. All mothers will receive a daily multivitamin and energy-protein supplement. Maternal cognition will be assessed longitudinally in the community setting at baseline, 24¿2 and 34¿2 wks gestation and 6 and 9 mo lactation by Raven's Colored Progressive Matrices and Kaufman-ABC. Post-partum depression will be assessed by the Edinburgh Post-Partum Depression Scale and maternal-infant interaction by the Nursing Child-Assessment-Feeding and Teaching Scales (NCAST). At age 6 (prior to supplementation) and 9 mo, infant neurocognitive development will be assessed by Novelty Preference; temperament by Laboratory Temperament Assessment Battery plus Bayley Behavior Record; motor function will be assessed by Bayley PDI. Infant head circumference, weight and length will be measured 3 days post- delivery and then monthly. Secondary outcome measures are: incidence of infectious disease morbidity; pre- and post-natal growth; Zn concentrations in maternal plasma and breast milk and the quantity of Zn absorbed. A range of statistical analyses will be used to examine the effects of the 1st RCT (one-way design with 3 groups) and the 2nd RCT (2x3 factorial) with two-sided significance at p=0.05. Improved understanding of the role of Zn is essential to overall understanding of the impact of malnutrition on maternal-infant brain function and development and, thence, to developing optimal public health strategies for the prevention of nutrition-related disorders of brain function.