Human Subjects and Sampling Core

人类受试者和采样核心

• 批准号: 10335256
• 负责人: Jose F Cordero
• 金额: $ 36.9万
• 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 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10335256
• 关键词: Adherence; Affect; Archives; Aromatic Polycyclic Hydrocarbons; Biological; Birth; Birth Rate; Chemicals; Clinic; Collaborations; Collection; Communities; Data; Data Analyses; Databases; Drops; Ensure; Environmental Exposure; Environmental Pollution; Exposure to; Fetal Growth Retardation; Funding; Gestational Diabetes; Health; Health Care Costs; Home; Hospitals; Human; Individual; Infrastructure; Interview; Knowledge; Laboratories; Link; Live Birth; Low Birth Weight Infant; Medical Records; Metals; Modeling; Participant; Pesticides; Physicians; Placenta; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnant Women; Premature Birth; Process; Protocols documentation; Public Health; Public Health Schools; Puerto Rico; Records; Research; Research Personnel; Research Training; Resources; Sample Size; Sampling; Ships; Site; Source; Specimen; Standardization; Student recruitment; Study Subject; System; Team Nursing; Time; Training; Translating; Umbilical Cord Blood; United States; Universities; Visit; Water; Work; adverse pregnancy outcome; base; cohort; community engagement; data management; data sharing; environmental agent; experience; follow-up; graduate student; ground water; human subject; interest; landfill; multiple data sources; phthalates; pollutant; pregnant; prenatal; prevent; programs; quality assurance; recruit; remediation; repository; success; superfund chemical; superfund site; systems research; time use; volatile organic compound

PROJECT SUMMARY Adverse pregnancy outcomes (APOs), such as preterm birth and low birth weight, are a major, costly health problem[1, 2]. Compared to the United States overall, significantly higher rates of preterm birth exist in Puerto Rico, where nearly 11.4% of all births in 2017 are preterm. Rates of low birth weight in Puerto Rico are likewise much higher than the U.S. average. Evidence exists that exposure to Superfund chemicals contributes to APOs. 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. The focus in this submission is to study the impact of specific mixtures of environmental contaminants on APOs. The set of mixtures selected for study are environmental agents with potential for adverse health effect in the prenatal period and are consistently found in PROTECT participants. The Human Subjects and Sampling Core (HSSC) provides a single point of contact to obtain data and biological and environmental samples linked to human subjects. For this renewal, the HSSC will maintain and enhance the infrastructure needed to recruit pregnant women from the northern karst region of Puerto Rico to participate in the program’s longitudinal research (Aim 1). The HSSC will build on the experience of partners from the University of Puerto Rico School of Public Health and the University of Georgia, who have recruited cohorts of pregnant women for diverse studies over the last decade. In the current funding period, HSSC formed and trained a team of nurses, physicians, support staff and graduate students that recruited and retained 1457 pregnant women with over 1280 followed until they completed pregnancy (including 1210 live births.) The intent of the proposed renewal is to recruit an additional 1000 participants, ultimately yielding a cohort of over 2,000 complete births. In addition to recruiting, the HSSC will systematically collect and share multiple sources of data. To acquire detailed information on potential predictors of APOs, the HSSC will conduct sequential interviews with study subjects, abstract medical records, and collect biological and environmental samples during pregnancy, delivery and postpartum (Aim 2). Because many of the projects have the same data or sample needs, a single systematic process for collection and sharing data and samples avoids duplication of effort and decreases the contact time with study subjects. This is a better use of time and available resources and reduces participant burden. The HSSC will process, archive and distribute samples to project investigators, and in collaboration with the Data Management and Analysis Core, maintain a repository of samples with an integrated database (Aim 3).

项目摘要 不良怀孕结果（APO），例如早产和低出生体重，是一个主要的，昂贵的健康 问题[1，2]。与美国总体上相比，波多黎各的早产率显着更高 Rico，2017年所有分娩的近11.4％是早产。波多黎各的低出生体重率同样 高于美国平均水平。有证据表明，接触超级基金化学物质有助于 apos。建立于2010年的波多黎各测试地，用于探索污染威胁中心（Protect） 使用整体研究，培训和利益相关者参与系统来研究运输，曝光，健康 污染物的影响和修复。此提交的重点是研究特定的影响 APO上环境污染物的混合物。选择用于研究的混合物是环境 在产前时期有潜在不良健康效应的代理商，并且在保护中始终发现 参与者。人类受试者和采样核心（HSSC）提供了一个接触点以获取数据 以及与人类受试者相关的生物和环境样本。为此，HSSC将保持 并增强从波多黎各北部喀斯特地区招募孕妇所需的基础设施 Rico参加该计划的纵向研究（AIM 1）。 HSSC将基于 波多黎各大学公共卫生学院和佐治亚大学的合伙人 在过去的十年中，招募了孕妇进行潜水员研究。在当前的资金期间， HSSC成立并培训了一组护士，医生，支持人员和研究生，并 保留了1457名超过1280的孕妇，直到他们完成怀孕（包括1210 Live 出生。）拟议续约的目的是招募另外1000名参与者，最终产生 队列超过2,000个完整的分娩。除招聘外，HSSC还将系统地收集和分享 多个数据源。为了获取有关APO的潜在预测指标的详细信息，HSSC将 与研究对象，摘要医疗记录并收集生物学和 怀孕，分娩和产后期间的环境样本（AIM 2）。因为许多项目 有相同的数据或样本需求，一个用于收集和共享数据和样本的系统系统过程 避免重复努力并减少与研究对象的接触时间。这是更好地利用时间， 可用的资源并减少了伯恩的参与者。 HSSC将处理，存档和分发样品 项目调查人员，并与数据管理和分析核心合作，维护存储库 具有集成数据库的样品（AIM 3）。