Core C: Human Subjects and Sampling Core

核心 C：人类受试者和采样核心

• 批准号: 8649393
• 负责人: Jose F Cordero
• 金额: $ 44.24万
• 依托单位: NORTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-12 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8649393
• 关键词: Adherence; Aliquot; Archives; Attention; Biological; Birth Rate; Chronic; Clinic; Collaborations; Collection; Computer software; Data; Data Collection; Data Set; Data Sources; Databases; Developmental Disabilities; Discipline of obstetrics; Ensure; Environmental Pollution; Exposure to; Funding; Hazardous Chemicals; Hazardous Waste Sites; Health; Home environment; Hospitals; Individual; Interview; Investigation; Knowledge; Laboratories; Link; Live Birth; Location; Malawi; Medical; Medical Records; Modeling; Neonatal Mortality; Participant; Pathway interactions; Physicians; Placenta; Postpartum Period; Pregnancy; Pregnant Women; Premature Birth; Process; Protocols documentation; Public Health; Public Health Schools; Puerto Rico; Qualifying; Questionnaires; Records; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Research Support; Research Training; Resources; Risk; Sampling; Sampling Studies; Science; Shipping; Ships; Site; Solvents; Specificity; Specimen; Study Subject; Surveys; System; Team Nursing; Time; Training; Translating; Transport Process; Umbilical Cord Blood; Visit; Water; Woman; abstracting; base; cohort; data management; data mining; experience; follow-up; graduate student; human data; human subject; landfill; phthalates; pregnant; prevent; programs; quality assurance; remediation; repository; skills; success; superfund site; systems research; time use; water quality; water sampling

PROJECT SUMMARY Preterm birth, the leading cause of neonatal mortality in the U.S., is also associated with a number of chronic health conditions and developmental disabilities that cause lifelong consequences. In Puerto Rico, the preterm birth rate is 17.7% of live births. At 50% above the U.S. average, it is the highest rate of any U.S. jurisdiction, below only Malawi (18.1%) globally. Our investigations suggest that the increase in preterm birth rates in Puerto Rico cannot be explained by changes in obstetric practices, and that there is strong evidence that exposure to hazardous chemicals contributes to preterm birth. Puerto Rico has 16 active Superfund sites and 200+ hazardous waste sites. Risk of exposure to contamination is high as many of these sites are unlined landfills that overlie karst aquifers which present highly susceptible pathways for exposure to contamination. Established in 2010, the Puerto Rico Testsite for Exploring Contamination Threats Center (PROTECT) uses a holistic system of research, training and stakeholder engagement to study transport, exposure, health impact and remediation of contaminants, with particular attention to chlorinated solvents and phthalates commonly found at Superfund sites, as both suspect and model agents in the high preterm birth rates in Puerto Rico. The Human Subjects and Sampling Core (Core C) provides a single point of contact to obtain data and biological samples from study subjects and environmental samples linked to human subjects. This Core builds on the experience and skills of the UPR School of Public Health and the UPR Medical Sciences Campus in recruiting cohorts of pregnant women for diverse studies over the last decade. During the current funding period Core C formed and trained a team of nurses, physicians, support staff and graduate students to recruit 480 pregnant women. The team is on track to recruit 800 women by the end of year 4. This will continue in the proposed renewal for an additional 1000 study participants; ultimately yielding a cohort of 1,200+ live births needed for the projects. Detailed information on potential predictors of preterm birth is collected through standardized questionnaires administered three times during pregnancy and through systematic abstraction of medical record data. Biological samples are collected from pregnant women, and tap water samples are collected from their homes. All biological samples are processed by Core C, stored at -80oC and prepared for shipment. Using laboratory sample tracking software, researchers in Core C and the projects have real-time access to the sample/aliquot location in specific freezers and laboratories, sample volumes available, and information on sample chain of custody and previous or planned uses. Groundwater samples are collected throughout the year in collaboration with the U.S. Geological Survey and Project 4. Groundwater and tap water samples are analyzed for water quality and contaminants by Project 4. Batches of samples are shipped to investigators for analysis as required by individual projects. Data collected is exported to the Data Management Core for integration of all data sets to enable analysis and data mining by end-users.

项目摘要 早产是美国新生儿死亡率的主要原因，也与许多慢性有关 造成终生后果的健康状况和发育障碍。在波多黎各，早产 出生率是活产的17.7％。它比美国平均水平高出50％，是美国任何司法管辖区的最高率， 在全球仅低于马拉维（18.1％）。我们的调查表明，早产率的提高 波多黎各不能用产科实践的变化来解释，并且有强有力的证据表明 暴露于危险化学物质会导致早产。波多黎各有16个主动超级基金站点， 200多个危险废物站点。暴露于污染的风险很高，因为这些地点中有许多是无灯的 覆盖喀斯特含水层的垃圾填埋场，这些含水层具有高度易受污染的途径。 建立于2010年，用于探索污染威胁中心（Protect）的波多黎各测试地使用 整体研究，培训和利益相关者参与的系统 学习运输，曝光，健康影响 污染物的修复，特别注意氯化溶剂和邻苯二甲酸盐 在波多黎各的高早产出生率中，在超级基金地点发现了嫌疑人和模型代理。 人类受试者和采样核心（核心C）提供了一个接触点，以获取数据和 与人类受试者有关的研究对象和环境样本的生物样品。此核心构建 关于UPR公共卫生学院和UPR医学科学校园的经验和技能 在过去十年中，招募孕妇进行多种研究。在当前资金期间 Core C时期成立并培训了由护士，医师，支持人员和研究生组成的团队 480名孕妇。该团队有望在4年底之前招募800名女性。这将继续 提议续签另外1000名研究参与者；最终产生1,200多个活产的队列 项目需要。关于早产潜在预测因素的详细信息是通过 在怀孕期间和系统抽象的标准化问卷进行了三次 病历数据。从孕妇那里收集生物样品，而自来水样品是 从他们的家中收集。所有生物样品均由核心C处理，存储在-80oC中，并准备 运输。使用实验室样本跟踪软件，Core C和项目的研究人员具有实时 访问特定冰柜和实验室中的样品/等分试样位置，可用的样品量以及 有关监护链以及以前或计划中的用途的信息。收集地下水样品 全年与美国地质调查局和项目4合作。地下水和自来水 通过项目4分析样品的水质和污染物。 根据各个项目的要求进行分析的研究者。收集的数据将导出到数据 集成所有数据集的管理核心，以启用最终用户分析和数据挖掘。