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: 6327381
• 负责人: MARTHA M. WERLER
• 金额: $ 45.66万
• 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 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6327381
• 关键词: alcoholic beverage consumption; aspirin; caffeine; clinical research; coffee; congenital oral /facial /cranial defect; disease /disorder etiology; disease /disorder proneness /risk; embryo /fetus toxicology; epidemiology; gene environment interaction; human subject; ibuprofen; infant human (0-1 year); interview; maternal behavior; medical records; mother /embryo /fetus nutrition; nasal decongestants; nutrition related tag; questionnaires; smoking; telecommunications; tobacco abuse; vasoactive agent

DESCRIPTION: 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 continuation of 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, illnesses, and nutritional factors; and 4) possible gene/environment interactions. We propose an additional aim: 5) to examine HFM risk in relation to the combination of decongestant and cigarette use. Cases will be identified at tertiary care institutions in 26 metropolitan areas in the U.S. and Canada. Controls will be identified by the case infant's primary physician (pediatrician or family doctor) 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 (smoking, alcohol, coffee); and nutrition. Before the interview, each mother will be sent a medication identification booklet which includes color pictures of over 200 over-the-counter cough/cold and analgesic products to help recall of medications used during early pregnancy. 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. The original study expected to include 275 cases and 825 controls (3 controls per case) within 38 months of data collection. Ascertainment of cases has been lower than originally projected, with 77 percent of 275 (or 213) cases to be included by the end of data collection phase of the study. Continuation of the project for an additional 18 months will allow an additional 63 cases and 228 controls to be included. Thus, the original target number of cases and controls will be met.

描述：半面部微小症 (HFM)，第二常见的颅面部疾病 畸形，具有显着的功能和美观后果。尽管 实验证据表明血管病因，目前还没有 发表了 HFM 危险因素的流行病学研究，其原因仍然存在 很大程度上不为人知。 拟议的项目是多中心病例对照研究的延续 HFM 与 1) 母亲接触减充血剂有关； 2) 母体暴露 其他血管活性物质，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，例如其他药物、疾病和营养因素；和 4) 可能的基因/环境相互作用。我们提出一个额外的目标：5) 检查与减充血剂和香烟组合相关的 HFM 风险 使用。 26个大都市区的三级医疗机构将发现病例 在美国和加拿大。对照将根据病例婴儿的情况来确定 主治医师（儿科医生或家庭医生），并将包括下一个 案件发生后出生了三名婴儿。病例和对照的母亲将是 自案件查明之日起三个月内接受面谈 电话。标准化问卷详细询问了人口统计信息 因素；生殖、医疗和妊娠疾病史；药物使用； 行为（吸烟、饮酒、咖啡）；和营养。面试前，每个人 母亲将收到一本包含颜色的药物识别手册 超过 200 种非处方止咳/感冒和镇痛产品的图片可提供帮助 回忆怀孕早期使用的药物。的一个单独的组件 研究将收集研究婴儿的口腔细胞样本，并且 他/她的母亲和父亲。将拍摄标准化照片 将审查每个病例婴儿的医疗记录以进行 HFM 分类。 最初的研究预计包括 275 个病例和 825 个对照（3 个对照） 每个案例）在数据收集后 38 个月内。案件已查明 低于最初预计，275（或 213）起案件中的 77% 在研究的数据收集阶段结束时纳入。继续 该项目再延长 18 个月，将允许新增 63 例病例和 228 例病例。 要包含的控件。因此，病例和对照的原始目标数量 将会被满足。