CASE CONTROL STUDY OF HEMIFACIAL MICROSOMIA AND DRUG USE

半面畸形与药物使用的病例对照研究

• 批准号: 2733750
• 负责人: MARTHA M. WERLER
• 金额: $ 41.22万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2733750
• 关键词: alcoholic beverage consumption; aspirin; caffeine; cell type; clinical research; coffee; congenital disorders; congenital oral /facial /cranial defect; disease /disorder etiology; disease /disorder proneness /risk; epidemiology; gene environment interaction; human subject; ibuprofen; infant human (0-1 year); interview; maternal behavior; medical records; mother /embryo /fetus nutrition; mouth; nasal decongestants; nutrition related tag; parents; questionnaires; smoking; vasoactive agent

DESCRIPTION: (Adapted from Investigator's Abstract) Hemifacial microsomia (HFM), the second most common craniofacial malformation, has significant functional and cosmetic consequences. While experimental evidence suggests a vascular etiology, there have been no published epidemiologic studies of risk factors for HFM, and its causes remain largely unknown. The proposed project is a multicenter case-control study of HFM in relation to 1) maternal exposure to decongestants, 2) maternal exposure to other vasoactive agents (such as alcohol, coffee, cigarette smoking, aspirin, and ibuprofen), 3) maternal exposure to other environmental risk factors (such as other medications, illness and nutritional factors); and 4) eventual studies of possible gene/environment interactions. There will be 250 case infants with HFM and 750 control infants without congenital malformations or medical conditions requiring hospitalization. Cases will be identified within 12 months of age at tertiary care institutions in 15 metropolitan areas in the U.S. and Canada. Controls will be identified by the case infant's primary physician and will comprise the next three infants born after the case. Mothers of cases and controls will be interviewed within three months after the date of case ascertainment by telephone. The standardized questionnaire inquires in detail about demographic factors; reproductive, medical and pregnancy illness histories; medication use; behaviors; and nutrition. Before the interview, each mother will be sent a medication identification booklet which includes color pictures of OTC products to help with recall. A separate component of the study will be collection of buccal cell samples from the study infant and his/her mother and father. Standardized photographs will be taken and the medical record of each case infant will be reviewed for HFM classification. Exposure prevalences will be compared between mothers of cases and controls and relative risks will be estimated, while controlling for potential confounding factors.

描述：（改编自研究者摘要）半面矮小 (HFM)是第二常见的颅面畸形， 功能和外观的影响。 尽管实验证据表明 一种血管病因学，尚未发表流行病学研究， HFM的风险因素，其原因仍然在很大程度上未知。 拟议 项目是一项多中心病例对照研究，涉及1） 母体暴露于减充血剂，2）母体暴露于其他血管活性物质 药物（如酒精、咖啡、吸烟、阿司匹林和布洛芬）， 3)母亲暴露于其他环境风险因素（如 药物、疾病和营养因素）;以及4） 基因与环境的相互作用 将有250例婴儿 HFM和750名对照婴儿，没有先天性畸形或医疗缺陷。 需要住院治疗的情况。 将在12个月内确定病例 2005年15个大都市地区三级保健机构中的 美国和加拿大 对照组将通过病例婴儿的主要 医生和将包括未来三个婴儿出生后的情况。 病例和对照组的母亲将在三个月内接受采访， 通过电话确认案件的日期。 标准化问卷 详细询问人口因素;生殖、医疗和 妊娠病史;药物使用;行为;和营养。 面试前，每位妈妈都会被发一张用药标识 包括OTC产品彩色图片的小册子，以帮助召回。 本研究的一个单独组成部分将是收集口腔细胞样本 从研究婴儿及其母亲和父亲。 标准化 将拍摄照片，并将每个病例婴儿的医疗记录 审查HFM分类。 将比较暴露发生率 病例母亲和对照母亲之间的差异以及相对风险将被估计， 同时控制潜在的混杂因素。