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: 9116614
• 负责人: ANDREW OLSHAN
• 金额: $ 80万
• 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/9116614
• 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可以促进减少出生缺陷对公共卫生影响的持续进展，旨在确定可改变的生活方式，环境和遗传因素，这些因素有助于特定出生缺陷的风险自1996年以来，全国各地的出生缺陷研究和预防中心（CBDRP），由CDC的国家出生缺陷和发育障碍中心资助，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，它提供了一个前所未有的机会来评估妊娠早期各种母体暴露与特定重大结构性出生缺陷之间的潜在关联。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缺陷（BD-STEPS）将进一步深入研究出生缺陷研究的几个有前途的领域，这些领域具有最大的潜力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合作数据收集和研究企业的主要贡献者。NCCBDRP是位于北卡罗来纳州查佩尔山的北卡罗来纳州Gillings全球公共卫生学院流行病学系和位于北卡罗来纳州罗利的北卡罗来纳州公共卫生部的北卡罗来纳州出生缺陷监测项目（NCBSLP）之间的合作项目。NCCBDRP建立了一个杰出的和独特的基础设施，以实施BD-STEPS协议，并进行高质量的流行病学和其他研究，重点是出生缺陷的原因和预防。我们已经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，提供科学合理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提供了重要的援助和领导，包括流行病学，生物统计学，方法开发和试点设计，遗传学，研究实施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，并进行创新和合作研究。BD-STEPS的目的是确定可能增加受某些重大结构性出生缺陷影响的妊娠风险的妊娠早期可改变的母体暴露。NCCBDRP的具体目标是：（1）实施标准化BD-STEPS方案，作为NC BD-STEPS，包括（a）使用NC出生缺陷监测系统识别244例（在活产、死产和人工流产中）每年在研究地区出现研究方案中包含的17种出生缺陷中的一种或多种;（B）使用出生证明每年确定96名对照婴儿的随机样本;（c）使用摘要医疗记录和其他信息进行病例分类和确认的临床审查;（d）预先及跟进邮寄所有资料予可能参加者，包括自行收集唾液的工具，并向中央面谈机构提供联络资料;（e）获得参与者同意提取医疗记录;和（f）从北卡罗来纳州国家实验室获得残留的新生儿血斑。(2)为创新设计BD-STEPS访谈问题、调查方法和新的研究工具提供实质性的专门知识，包括与早孕暴露有关的有针对性的在线模块，如饮食、肥胖、体育活动、不孕症、职业和慢性疾病;（3）使用BD-开发创新的研究问题和建议STEPS和NBDPS数据，以确定可改变的出生缺陷风险因素，最大限度地影响公共卫生，分析遗传因素，进行严格的分析，在国家会议上提出调查结果，并在5年奖励期内发表至少10篇论文;（4）提供流行病学和生物统计方法方面的专业知识，例如偏差分析、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）开展创新的实验室研究，开发使用干血斑的创新方法，以调查包括有毒金属和其他暴露在内的出生缺陷的潜在风险因素;（6）参与与其他CBDRP和CDC的合作活动和研究计划;（7）继续培养出生缺陷流行病学领域的初级研究人员。通过纳入多个研究中心，BD-STEPS旨在研究代表美国人群种族/民族组成的研究人群。项目周期预计为2013年8月1日至2018年7月31日。