CASE CONTROL SURVEILLANCE OF BIRTH DEFECTS

出生缺陷病例对照监测

• 批准号: 2200580
• 负责人: ALLEN A MITCHELL
• 金额: $ 63.4万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-04-01 至 1997-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2200580
• 关键词: biomarker; blood chemistry; congenital skeletal disorder; data collection methodology /evaluation; embryo /fetus death; embryo /fetus disorder; embryo /fetus drug adverse effect; embryo /fetus toxicology; environmental toxicology; epidemiology; fetal alcohol syndrome; human subject; induced abortion; interview; neural plate /tube; questionnaires; spontaneous abortion; statistics /biometry; teratogens; tissue resource /registry

Affecting 3 to 4% of liveborn infants, birth defects constitute a major health problem, and are now the leading cause of infant mortality in the U.S. Though genetic and chromosomal causes are well described, the majority of birth defects are believed to result from environmental exposures. However, only a small number of agents are known teratogens, and even fewer have been shown to be safe. Every year, new agents are alleged to be teratogenic -- allegations which, because of intense public interest in birth defects and the environment, directly affect the public health and require prompt scientific response. Ongoing case-control surveillance can provide important knowledge about environmental teratogens through the systematic study of birth defects in relation to environmental agents to which pregnant women are exposed, particularly medications and health habits (e.g., smoking). We propose to maintain and expand an existing system of case-control surveillance for birth defects in relation to environmental exposures. Subjects will be drawn from three geographic centers serving a heterogeneous population (the metropolitan areas of Boston, Philadelphia, and Toronto), and will include liveborn and stillborn infants and therapeutic abortuses with major structural malformations, as well as non- malformed subjects, identified through a multi-level ascertainment procedure in each center. Mothers of subjects will be interviewed in their homes by nurses who will administer a detailed and structured questionnaire that elicits information on a wide range of demographic and medical factors, medication use, diet, and health behaviors. A blood sample will also be obtained for testing of biologic markers. This proposal will enable us to: test hypotheses in existing data or through accrual of additional data; generate hypotheses through systematic review of the data; and test and generate hypotheses related to biologically-determined variations in the disposition of drugs and other agents among population subgroups. Should the testing of a new epidemiologic or biologic hypothesis require additional data, the proposed system will facilitate a prompt and efficient response through enhanced accrual of specific defects, modification of the study design and data collection, and modification in the collection of additional biologic markers -- all of which can be accomplished within a few months, rather than years, as is normally required from the time of a study's proposal to the initiation of data collection.

影响3%至4%的活产婴儿，出生缺陷构成主要的 目前，这些疾病是非洲婴儿死亡的主要原因。 美国 虽然遗传和染色体的原因是很好的描述， 大多数出生缺陷被认为是由环境造成的。 暴露。 然而，只有少量的物质是已知的致畸剂， 更少的被证明是安全的。 每年都有新的特工 据称具有致畸性--由于公众的强烈关注，这些指控 对出生缺陷和环境的兴趣，直接影响到公众 需要迅速作出科学反应。 正在进行的病例对照 监测可以提供有关环境致畸物的重要知识 通过系统研究出生缺陷与环境的关系， 孕妇接触的物质，特别是药物， 健康习惯（例如，吸烟）。 我们建议维持和扩大现有的个案控制制度 监测与环境暴露有关的出生缺陷。 受试者将从三个地理中心抽取， 异质人口（波士顿，费城， 和多伦多），并将包括活产和死胎婴儿， 治疗性流产的主要结构畸形，以及非 畸形受试者，通过多层次确定 每个中心的程序。 受试者的母亲将接受采访， 护士将管理一份详细的结构化问卷， 该系统提供了有关人口和医疗方面广泛信息， 因素、药物使用、饮食和健康行为。 血液试样将 也可用于生物标志物的检测。 这一建议将使我们能够：在现有数据中检验假设， 通过增加额外的数据;通过系统的 审查数据;并测试和生成与以下内容相关的假设： 生物学决定的药物处置和其他 人口亚组中的代理人。 一个新的测试 流行病学或生物学假设需要额外的数据， 该系统将通过加强 特定缺陷的累积、研究设计和数据的修改 收集和修改额外的生物制品 所有这些都可以在几个月内完成， 一般来说，从提出研究建议之时起， 开始数据收集。