A Prospective Birth Cohort Study Involving Uranium Exposure in the Navajo Nation

描述（由申请人提供）：应社区要求，将建立一个纳瓦霍出生队列，通过以下具体目标研究环境暴露于铀和相关采矿废物对纳瓦霍母亲及其后代的产前、围产期和产后早期健康影响：合作设计并开展一项纳瓦霍族母婴接触铀废物与妊娠结局和儿童发育相关的前瞻性流行病学出生队列研究。1. 征求社区、纳瓦霍人和联邦机构的意见，为最终的研究设计提供信息，以确保它尊重纳瓦霍文化，并包括解决社区关切的适当措施。招募1650名妊娠早期（妊娠1或2个月早期，如果可行）的孕妇，并在整个妊娠和分娩过程中跟踪她们（假设妊娠损失率为10%）。建立一个由这些妇女的1500名子女组成的出生队列，对这些妇女的出生、生长和神经发育结果进行评估和跟踪，直到12个月大（在随访的初始阶段）。比较更可能和更不可能接触铀及相关金属的母亲及其子女的健康终点（由扩大的研究小组最终确定）。目标2：描述可能影响结果的流动性、暴露、共同暴露、人口统计学和文化特征方面的队列特征。测量/估计人类对铀和其他毒物的暴露，并确定暴露途径2。使用地理空间统计来确定暴露“热点”作为暴露3的替代。目标3：在我们扩大的社区联络小组（CLG）的指导下，与社区卫生工作者合作，就研究目标和结果、产前护理、现有临床服务以及减轻任何暴露对纳瓦霍人健康的影响进行广泛的宣传。目标4：与纳瓦霍机构伙伴合作，发展其环境卫生能力，并为该队列的持续后续行动制定可持续性计划。这项工作将通过与ATSDR/CDC的合作协议完成，并让机构科学家和社区参与最终设计的开发和实施。研究小组将流行病学、毒理学、数学和建模以及环境评估方面的科学专业知识与纳瓦霍文化和语言专家、传统医学专家、纳瓦霍国家机构以及临床护理提供者的参与相结合，确保不仅尊重设计和实施，而且有效地将结果转化为政策、卫生保健以及有效的社区推广和教育。

DESCRIPTION (provided by applicant): In response to community requests, a Navajo Birth Cohort will be developed to study the prenatal, perinatal, and early postnatal health effects of environmental exposures to uranium and associated mining wastes on Navajo mothers and their offspring through the following specific aims: Aim 1: Co-operatively design and conduct a prospective epidemiologic birth cohort study of pregnancy outcomes and child development in relation to uranium waste exposures among Navajo mother-infant pairs. 1. Solicit community, Navajo and federal agency input, to inform the final study design to ensure it is respectful of Navajo culture and includes appropriate measures to address community concerns 2. Enroll 1,650 pregnant women in early pregnancy (1st or early 2nd trimester, as feasible) and follow them throughout pregnancy and childbirth (assumes a pregnancy loss rate of 10%) 3. Establish a birth cohort of 1,500 offspring of these women who will be assessed and followed for birth, growth, and neurodevelopmental outcomes to 12 months of age (in the initial phase of follow-up) 4. Compare health endpoints (as finalized by the expanded Research Team) among mothers and their children who are more and less likely to be exposed to uranium and associated metals. Aim 2: Characterize the cohort with respect to mobility, exposures, co-exposures, demographic and cultural characteristics that may influence outcomes 1. Measure/estimate human exposures to uranium and other toxicants, and identify exposure pathways 2. Use geospatial statistics to identify exposure "hot spots" as surrogates for exposure 3. Collect information on potential modifiers of susceptibility, such as diet and psychosocial stress Aim 3: With guidance from our expanded Community Liaison Group (CLG) and collaboration with community health workers, provide extensive outreach on the study goals and results, on prenatal care, available clinical services, and mitigation of any exposure-induced health effects on Navajo. Aim 4: Work with Navajo agency partners to develop their environmental health capacity and to develop a sustainability plan for continued follow-up of the cohort. This work will be accomplished through a cooperative agreement with ATSDR/CDC and involve agency scientists as well as communities in development and implementation of the final design. The Research Team combines scientific expertise in epidemiology, toxicology, mathematics and modeling, and environmental assessment with participation of Navajo culture and language experts, traditional medicinemen, and Navajo Nation agencies as well as clinical care providers to ensure not only respectful design and implementation, but effective translation of the results to policy, health care, and effective outreach and education for communities. PUBLIC HEALTH RELEVANCE: Navajo communities have been exposed to legacy waste of uranium mining for more than 50 years. Community members are concerned that the exposures have lead to reproductive toxicity as well as impaired development in their children. Similar concerns have been raised in other communities where uranium exposures have occurred but no definitive studies have been conducted in humans. In the proposed Navajo Birth Cohort study we will examine the reproductive outcomes in pregnant women, follow and assess their children for 3 months to 1 year of age, and set up a system to allow follow up through childhood age 6 to evaluate the impacts of uranium exposure on biological and psychosocial endpoints. The research will be conducted by a team of research scientists, Navajo and federal agency representatives, clinicians, and Navajo culture and language experts using community-based techniques.