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: 8722861
• 负责人: ANDREW OLSHAN
• 金额: $ 76.5万
• 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/8722861
• 关键词: North; Carolina; Birth; Defects; Study

DESCRIPTION (provided by applicant): 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 classificaton 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.

描述（由申请人提供）：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。以人群为基础的流行病学研究旨在确定导致特定出生缺陷风险的可改变生活方式、环境和遗传因素，从而在减轻出生缺陷对公共健康影响方面不断取得进展。自 1996 年以来，出生缺陷研究和预防中心全国出生缺陷预防研究 (NBDPS) 在 CDC 国家出生缺陷和发育障碍中心的资助下，在全国范围内合作开展了国家出生缺陷预防研究 (NBDPS)。 NBDPS 是一项以人群为基础的多中心病例对照研究，为评估孕早期各种孕产妇暴露与特定的主要结构性出生缺陷之间的潜在关联提供了前所未有的机会。新的出生缺陷评估妊娠暴露研究 (BD-STEPS) 将 NBDPS 研究经验作为创新的基础，进一步深入探讨出生缺陷研究的几个有前途的领域，这些领域最有可能转化为出生缺陷预防工作。北卡罗来纳州出生缺陷研究和预防中心 (NCCBDRP) 成立于 2002 年秋季，一直是 NBDPS 协作数据收集和研究事业的主要贡献者。 NCCBDRP 是北卡罗来纳大学吉林斯全球公共卫生学院流行病学系和北卡罗来纳州公共部门北卡罗来纳出生缺陷监测项目 (NCBDMP) 之间的合作项目。北卡罗来纳州罗利市的健康状况。 NCCBDRP 建立了出色且独特的基础设施来实施 BD-STEPS 协议并开展高质量的流行病学和其他研究，重点关注出生缺陷的原因和预防。我们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，提供具有科学依据的高质量数据和标本收集，并提供科学监督。从历史上看，NCCBDRP 在许多领域为 NBDPS 提供了重要的帮助和领导，包括流行病学、生物统计学、方法开发和试点设计、遗传学、研究行为以及访谈和实验室程序的质量控制。我们非常有能力实施新的 BD-STEPS 协议以及开展创新和协作研究。 BD-STEPS 的目的是确定妊娠早期可改变的孕产妇暴露，这些暴露可能会增加妊娠受某些重大结构性出生缺陷影响的风险。 NCCBDRP 的具体目标是 (1) 实施标准化 BD-STEPS 协议作为 NC BD-STEPS，包括 (a) 使用 NC 出生缺陷监测系统识别 244 例病例（包括活产、死产和人工流产）每年研究方案中包含的 17 种出生缺陷中的一种或多种的研究区域； (b) 每年利用出生证明随机抽取 96 名对照婴儿作为样本； (c) 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；(d) 向潜在参与者进行所有预先和后续邮寄，包括用于自我收集唾液的工具包，并向中央访谈提供联系信息机构; (e) 获得参与者同意提取医疗记录； (f) 从北卡罗来纳州立实验室获取残留的新生儿血斑。 (2) 为 BD-STEPS 访谈问题、调查方法和新颖研究工具的创新设计提供实质性专业知识，包括与饮食、肥胖、体力活动、不孕症、职业和慢性病等早期妊娠暴露相关的有针对性的在线模块； (3) 使用 BD-STEPS 和 NBDPS 数据制定创新的研究问题和建议，以确定对公共健康影响最大的可改变的出生缺陷风险因素，分析遗传因素，进行严格的分析，在全国会议上展示研究结果，并至少发表5年奖励期内论文10篇； (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、缺失数据、相关暴露、合并样本、基因集分析方法、多个SNP、单倍型、GWAS和表观遗传学； (5) 开展创新实验室研究，开发利用干血斑的创新方法来调查出生缺陷的潜在危险因素，包括有毒金属和其他暴露； (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。通过纳入多个研究地点，BD-STEPS 的目标是研究能够代表美国人口种族/民族构成的研究人群。项目期预计为2013年8月1日至2018年7月31日。