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）：在美国，先天缺陷是婴儿死亡率，发病率和医疗保健费用的主要原因，但大多数先天缺陷的病因仍然未知。 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预防研究（NBDP）。 NBDP是一项基于人群的多中心病例对照研究，它提供了一个前所未有的机会，可以评估怀孕早期期间各种母体暴露与特定的主要结构性先天缺陷之间的潜在关联。利用NBDP，研究经验是创新的基础，新的出生缺陷研究以评估怀孕暴露（BD-Steps）将进一步研究一些有希望的出生缺陷研究领域，这些研究具有最大的转化为预防出生缺陷的潜力。北卡罗来纳州先生缺陷研究与预防中心（NCCBDRP）成立于2002年秋季，是NBDPS合作数据收集和研究企业的主要贡献者。 NCCBDRP是北卡罗来纳州北卡罗来纳大学吉林斯大学全球公共卫生学院流行病学系（UNC）（UNC）的全球公共卫生学院与北卡罗来纳州北卡罗来纳州Raleigh公共卫生部北卡罗来纳州公共卫生部门的北卡罗来纳州出生缺陷监测计划（NCBDMP）之间的合作努力。 NCCBDRP建立了一个出色的独特基础设施来实施BD-Steps协议，并进行高质量的流行病学和其他研究，重点介绍了出生缺陷的原因和预防。我们组建了一个令人印象深刻的调查员和员工团队，为国家研究设计做出了贡献，为科学的辩护和高质量的数据和标本收集提供了贡献，并提供了科学的监督。从历史上看，NCCBDRP在许多领域为NBDP提供了关键的帮助和领导，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。我们在实施新的BD-Steps协议以及进行创新和协作研究方面非常有位置。 BD步骤的目的是确定早期怀孕的可修改母体暴露，这可能会增加患有某些主要的结构性先天缺陷影响怀孕的风险。 NCCBDRP的具体目的是（1）将标准化的BD-Steps协议作为NC BD-Steps实施，包括（a）使用NC先生缺陷监视系统在每年在研究区域中识别244例（在LiveBirth，Stiltbirths，Stiltbirths和诱发的中断中），其中17个或更多的生物出生缺陷中的一项研究领域包括一项或更多的生物性研究。 （b）使用出生证明每年确定每年96名对照婴儿的随机样本； （c）对病例分类进行临床审查，并使用摘要的医疗记录和其他信息进行确认；（d）向潜在参与者进行所有预付款和后续邮件，包括用于自我收集的工具包，并向中央面试机构提供联系信息； （e）从参与者获得抽象病历的同意； （f）从北卡罗来纳州实验室获得残留的新生儿血斑。 （2）为BD步骤的访谈问题，调查方法和新型研究工具的创新设计提供实质性专业知识，包括与早期妊娠暴露有关的有针对性的在线模块，例如饮食，肥胖，身体活动，不育，职业和慢性病； （3）使用BD步骤和NBDPS数据制定创新的研究问题和建议，以确定具有最大潜力的出生缺陷的可修改风险因素，对公共卫生的影响最大，分析遗传因素，进行严格的分析，在国家会议上进行介绍，并在5年奖励期间发表至少10篇论文； （4）提供有关流行病学和生物统计学方法的专业知识，例如偏差分析，缺失数据，相关暴露，汇集样本，用于分析基因集，多种SNP，单倍型，GWAS，GWAS和表观遗传学的方法； （5）进行创新的实验室研究，以开发创新的方法，用于使用干血点调查包括有毒金属和其他暴露在内的先天缺陷的潜在危险因素； （6）与其他CBDRP和CDC一起参加了协作活动和研究计划； （7）继续培训流行病学领域的初级研究人员。通过包括多个研究地点，BD步骤将旨在代表美国种族/族裔组成的美国人口的研究人群。预计项目期限为2013年8月1日 - 7/31/2018。