North Carolina Birth Defects Study To Evaluate Pregnancy Exposures (NC BD-STEPS)

评估妊娠暴露的北卡罗来纳州出生缺陷研究 (NC BD-STEPS)

• 批准号: 8610032
• 负责人: ANDREW OLSHAN
• 金额: $ 35万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8610032
• 关键词: North; Carolina; Birth; Defects; Study

Project Abstract Birth defects are a leading cause of infant mortality, morbidity and healthcare costs in the United States, yet the etiology of most birth defects remains unknown. Continued progress toward lessening the public health impact of birth defects can be facilitated by population-based epidemiologic research aimed at identifying modifiable lifestyle, environmental and genetic factors that contribute to the risk for specific birth defects. Since 1996, the Centers for Birth Defects Research and Prevention (CBDRP) across the nation, funded by the CDC's National Center on Birth Defects and Developmental Disabilities, have collaborated on the National Birth Defects Prevention Study (NBDPS). The NBDPS was a population-based, multi-center case-control study which provided an unprecedented opportunity to assess the potential association between a variety of maternal exposures during early pregnancy and specific major, structural birth defects. Using the NBDPS research experience as a foundation from which to innovate, the new Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) will delve further into several promising areas of birth defects research that have maximum potential for translation to birth defects prevention efforts. The North Carolina Center for Birth Defects Research and Prevention (NCCBDRP) was established in Fall 2002 and has been a major contributor to the collaborative data collection and research enterprise of the NBDPS. The NCCBDRP is a collaborative effort between the Department of Epidemiology at the University of North Carolina Gillings School of Global Public Health in Chapel Hill, NC (UNC), and the North Carolina Birth Defects Monitoring Program (NCBDMP) at the North Carolina Division of Public Health in Raleigh, NC. The NCCBDRP has established an outstanding and unique infrastructure to implement the BD-STEPS protocol and to conduct high quality epidemiologic and other research focused on the causes and prevention of birth defects. We have assembled an impressive team of investigators and staff to contribute to the national study design, contribute scientifically defensible and high quality data and specimen collection, and provide scientific oversight. Historically, the NCCBDRP has provided critical assistance and leadership to the NBDPS in many areas including epidemiology, biostatistics, method development and pilot design, genetics, study conduct, and quality control for interviewing and laboratory procedures. We are very well positioned to implement the new BD-STEPS protocol as well as to conduct innovative and collaborative research. The purpose of BD-STEPS is to identify modifiable maternal exposures in early pregnancy that may increase the risk for having a pregnancy affected by certain major, structural birth defects. The specific aims of the NCCBDRP are to (1) Implement the standardized BD-STEPS protocol as the NC BD-STEPS, including (a) use the NC birth defects surveillance system to identify 244 cases (among livebirths, stillbirths and induced abortions) in the study area each year with one or more of the 17 birth defects included in the study protocol; (b) identify a random sample of 96 control infants per year using birth certificates; (c) conduct clinical review for case classification and confirmation using abstracted medical records and other information;(d) conduct all advance and follow-up mailings to potential participants including kits for self- collection of saliva, and provide contact information to the central interviewing agency; (e) obtain consent from participants to abstract medical records; and (f) obtain residual newborn blood spots from the North Carolina State Laboratory. (2) Provide substantive expertise for the innovative design of BD-STEPS interview questions, survey methods and novel study instruments including targeted online modules related to early pregnancy exposures such as diet, obesity, physical activity, infertility, occupation and chronic medical conditions; (3) Develop innovative study questions and proposals using BD-STEPS and NBDPS data to identify modifiable risk factors for birth defects with maximum potential for public health impact, analyze genetic factors, conduct rigorous analyses, present findings at national meetings, and publish at least 10 papers during the 5-year award period; (4) Provide expertise on epidemiologic and biostatistical methods such as bias analysis, missing data, correlated exposures, pooled samples, approaches for the analysis of gene sets, multiple SNPs, haplotypes, GWAS and epigenetics; (5) Conduct innovative laboratory research to develop innovative methods for using dried blood spots to investigate potential risk factors for birth defects including toxic metals and other exposures; (6) Participate in collaborative activities and research initiatives with other CBDRP and the CDC; and (7) Continue to train junior researchers in the field of birth defects epidemiology. By including multiple study sites, BD-STEPS will aim for a study population that is representative of the US population in racial/ethnic composition. The project period is anticipated to be 8/1/2013 - 7/31/2018.

项目摘要 出生缺陷是美国婴儿死亡率、发病率和医疗费用的主要原因，但 大多数出生缺陷的病因仍不清楚。在减轻公众健康方面持续取得进展 可以通过旨在确定出生缺陷的人口流行病学研究来促进出生缺陷的影响 可改变的生活方式、环境和遗传因素会导致特定出生缺陷的风险。自从 1996 年，由 CDC 资助的全国出生缺陷研究和预防中心 (CBDRP) 国家出生缺陷和发育障碍中心，合作开展了国家出生 缺陷预防研究（NBDPS）。 NBDPS 是一项基于人群的多中心病例对照研究 这提供了一个前所未有的机会来评估各种不同类型之间的潜在关联 孕早期母亲的暴露和特定的重大结构性出生缺陷。使用 NBDPS 研究经验作为创新的基础，新的出生缺陷研究评估 妊娠暴露（BD-STEPS）将进一步深入研究出生缺陷研究的几个有前景的领域 具有转化为出生缺陷预防工作的最大潜力。北卡罗来纳州中心 出生缺陷研究与预防 (NCCBDRP) 成立于 2002 年秋季，一直是 NBDPS 协作数据收集和研究企业的贡献者。 NCCBDRP 是 北卡罗来纳大学吉林斯分校流行病学系之间的合作 北卡罗来纳州教堂山全球公共卫生学院 (UNC) 和北卡罗来纳州出生缺陷监测中心 位于北卡罗来纳州罗利的北卡罗来纳州公共卫生部门的计划 (NCBDMP)。 NCCBDRP 有 建立了出色且独特的基础设施来实施 BD-STEPS 协议并进行高 质量流行病学和其他研究的重点是出生缺陷的原因和预防。我们有 组建了一支令人印象深刻的研究人员和工作人员团队，为国家研究设计做出贡献， 科学论证、高质量的数据和标本采集，并提供科学监督。 从历史上看，NCCBDRP 在许多领域为 NBDPS 提供了重要的协助和领导 包括流行病学、生物统计学、方法开发和试点设计、遗传学、研究行为和 访谈和实验室程序的质量控制。我们处于非常有利的位置来实施新的 BD-STEPS 协议以及进行创新和协作研究。 BD-STEPS 的目的是确定妊娠早期可改变的孕产妇暴露，这些暴露可能 增加怀孕时受某些重大结构性出生缺陷影响的风险。具体的 NCCBDRP 的目标是 (1) 实施标准化 BD-STEPS 协议作为 NC BD-STEPS， 包括 (a) 使用北卡罗来纳州出生缺陷监测系统识别 244 例（活产、死产） 每年在研究地区存在 17 种出生缺陷中的一种或多种 研究方案； (b) 每年利用出生证明随机抽取 96 名对照婴儿作为样本； (c) 行为 使用提取的医疗记录和其他信息进行病例分类和确认的临床审查 信息；(d) 向潜在参与者发送所有预先和后续邮件，包括用于自助的工具包 收集唾液，并向中央访谈机构提供联系方式； (e) 获得同意 参与者提取医疗记录； (f) 从北卡罗来纳州获得残留的新生儿血斑 国家实验室。 （2）为BD-STEPS面试问题的创新设计提供实质性专业知识， 调查方法和新颖的研究工具，包括与早期妊娠相关的有针对性的在线模块 饮食、肥胖、体力活动、不孕不育、职业和慢性病等暴露； (3) 使用 BD-STEPS 和 NBDPS 数据制定创新的研究问题和建议，以确定可修改的内容 对公共健康影响最大的出生缺陷风险因素，分析遗传因素，进行 严格分析，在全国会议上展示研究结果，并在 5 年内发表至少 10 篇论文 奖励期限； (4) 提供流行病学和生物统计学方法方面的专业知识，例如偏倚分析、缺失分析 数据、相关暴露、合并样本、基因组分析方法、多个 SNP、 单倍型、GWAS 和表观遗传学； （五）开展创新实验室研究，开发创新方法 使用干血斑调查出生缺陷的潜在危险因素，包括有毒金属和其他 曝光； (6) 参与与其他 CBDRP 和 CDC 的合作活动和研究计划； （七）继续培养出生缺陷流行病学领域的初级研究人员。通过包括多个 研究地点，BD-STEPS 将针对代表美国人口的研究人群 种族/民族构成。项目期预计为2013年8月1日至2018年7月31日。