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、发病率和医疗保健费用的主要原因， 大多数出生缺陷的病因仍然不明。在减少公共卫生方面继续取得进展 出生缺陷的影响可以通过以人群为基础的流行病学研究来促进， 可改变的生活方式，环境和遗传因素，有助于特定的出生缺陷的风险。以来 1996年，由疾病预防控制中心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，已经在国家出生 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疾病之间的潜在联系， 孕妇在怀孕早期受到的辐射以及特定的重大结构性出生缺陷。使用NBDPS 研究经验为基础，从创新，新的出生缺陷研究评价 怀孕检查（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 这是最有可能转化为出生缺陷预防工作的。北卡罗来纳州中心 出生缺陷研究和预防（NCCBDRP）成立于2002年秋季，一直是一个主要的 NBDPS的协作数据收集和研究企业的贡献者。NCCBDRP是一个 北卡罗来纳州吉林斯大学流行病学系之间的合作 位于北卡罗来纳州查佩尔山的全球公共卫生学院和北卡罗来纳州出生缺陷监测中心 在罗利的北卡罗来纳州公共卫生部的NCBSII项目。NCCBDRP已经 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 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， 科学上有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、研究实施，以及 面谈和实验室程序的质量控制。我们有能力实施新的 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母体暴露， 增加怀孕受某些重大结构性出生缺陷影响的风险。具体 NCCBDRP的目标是（1）将标准化的BD-STEPS协议实现为NC BD-STEPS， 包括（a）使用NC出生缺陷监测系统确定244例（活产、死产 和人工流产），其中17种出生缺陷中的一种或多种包括在 研究方案;（B）使用出生证明每年随机抽取96名对照婴儿;（c）进行 使用摘要病历和其他资料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发邮件和后续邮件， 收集唾液，并向中央面谈机构提供联系信息;（e）征得 参与者提取医疗记录;以及（f）从北卡罗来纳州获取残留的新生儿血点 国家实验室。(2)为BD-STEPS面试问题的创新设计提供实质性的专业知识， 调查方法和新的研究工具，包括与早孕有关的有针对性的在线模块 暴露，如饮食、肥胖、体力活动、不育、职业和慢性疾病;（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 对公共卫生影响最大的出生缺陷风险因素，分析遗传因素， 进行严格的分析，在国家会议上介绍研究结果，并在5年内发表至少10篇论文 （4）提供流行病学和生物统计学方法方面的专业知识，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、多种SNP， 单倍型、GWAS和表观遗传学;（5）开展创新的实验室研究，开发创新的方法 使用干血斑研究出生缺陷的潜在风险因素，包括有毒金属和其他 （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。通过包括多 研究中心，BD-STEPS将针对代表美国人群的研究人群， 种族/民族构成。项目周期预计为2013年8月1日至2018年7月31日。