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(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。旨在确定导致特定出生缺陷风险的可改变的生活方式、环境和遗传因素的基于人群的流行病学研究可以推动在减少出生缺陷对公众健康影响方面取得的持续进展。自1996年以来，全国出生缺陷研究和预防中心(CBDRP)在美国疾病控制与预防中心国家出生缺陷和发育障碍中心的资助下，合作开展了全国出生缺陷预防研究(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怀孕早期各种母亲接触与特定的重大结构性出生缺陷之间的潜在联系。利用NBDPS研究经验作为创新的基础，新的出生缺陷研究评估怀孕暴露(BD-STEPS)将进一步深入出生缺陷研究的几个有希望的领域，这些领域最有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是北卡罗来纳大学吉林斯全球公共卫生学院(北卡罗来纳大学教堂山分校)流行病学系和北卡罗来纳州罗利市公共卫生部北卡罗来纳州出生缺陷监测项目(NCBDMP)共同努力的成果。NCCBDRP建立了杰出和独特的基础设施，以执行BD-STEPS议定书，并开展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调查人员和工作人员团队，为国家研究设计做出贡献，为科学辩护和高质量的数据和标本收集做出贡献，并提供科学监督。从历史上看，NCCBDRP在流行病学、生物统计学、方法开发和试验设计、遗传学、研究指导以及访谈和实验室程序的质量控制等多个领域为NBDPS提供了关键的援助和领导。我们处于非常有利的地位，可以实施新的BD-STEP协议，并进行创新和合作研究。BD-STEPS的目的是确定怀孕早期可改变的母亲暴露可能增加怀孕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)执行标准化的BD-STEPS方案作为NC BD-STEP，包括(A)使用NC出生缺陷监测系统，每年在研究区域内识别244例病例(活产、死产和人工流产中)，其中一个或多个出生缺陷包括在研究方案中；(B)使用出生证明确定每年96名对照婴儿的随机样本；(C)利用抽象的医疗记录和其他信息对病例分类和确认进行临床审查；(D)对潜在参与者进行所有预先和后续邮寄，包括自行收集唾液的工具包，并向中央约谈机构提供联系信息；(E)征得参与者同意提取医疗记录；(F)从北卡罗来纳州实验室获取残留的新生儿血点。(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门知识，包括与早孕暴露相关的有针对性的在线模块，如饮食、肥胖、体力活动、不孕、职业和慢性医疗条件；(3)利用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出生缺陷的可改变风险因素，分析遗传因素，进行严格分析，在全国会议上提交研究结果，并在5年获奖期内发表至少10篇论文；(4)提供流行病学和生物统计学方法方面的专门知识，如偏差分析、缺失数据、相关暴露、汇集样本、基因组分析方法、多个SNPs、单倍型、GWAS和表观遗传学；(5)开展创新的实验室研究，以开发创新的方法，利用干血斑点调查出生缺陷的潜在风险因素，包括有毒金属和其他暴露；(6)参与与CBDRP和疾控中心的合作活动和研究倡议；以及(7)继续培训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将致力于建立一个在种族/民族构成上代表美国人口的研究群体。项目期预计为2018年8月1日至2018年7月31日。