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: 2015301
• 负责人: MARTHA M. WERLER
• 金额: $ 44.49万
• 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/2015301
• 关键词: alcoholic beverage consumption; aspirin; behavioral /social science research tag; 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）半面部短小症 (HFM) 是第二常见的颅面畸形，具有显着的 功能和美容效果。 虽然实验证据表明 血管病因，目前尚未发表流行病学研究 HFM 的危险因素及其原因仍然很大程度上未知。 拟议的 该项目是一项关于 HFM 的多中心病例对照研究：1) 母亲接触减充血剂，2) 母亲接触其他血管活性物质 药物（如酒精、咖啡、吸烟、阿司匹林和布洛芬）， 3) 产妇暴露于其他环境危险因素（如其他 药物、疾病和营养因素）； 4）最终研究 可能的基因/环境相互作用。 将会有 250 例婴儿患有 HFM 和 750 控制婴儿无先天畸形或医学 需要住院治疗的情况。 病例将在 12 天内确诊 15个大都市区三级保健机构的月龄 美国和加拿大。 对照将根据病例婴儿的主要情况来确定 医生，并将包括该病例后出生的接下来的三个婴儿。 病例和对照的母亲将在三个月内接受采访 通过电话查明案件的日期。 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。 在面谈之前，每位母亲都会收到一份药物证明 小册子，其中包含 OTC 产品的彩色图片，以帮助回忆。 该研究的一个单独部分是收集口腔细胞样本 来自研究婴儿及其父母。 标准化 将拍摄照片并记录每个病例婴儿的医疗记录 审查 HFM 分类。 将比较暴露率 将估计病例母亲和对照母亲之间的相对风险， 同时控制潜在的混杂因素。