CASE-CONTROL STUDY OF HEMIFACIAL MICROSOMIA AND DRUG USE

描述：半面部矮小(HFM)，第二常见的颅面 畸形，具有重大的功能和美容后果。而当 实验证据表明，这是一种血管病因学，没有 已发表的HFM危险因素的流行病学研究及其原因仍在 很大程度上是未知的。 拟议的项目是一项多中心病例对照研究的延续。 HFM与1)母亲接触减充血剂；2)母亲接触 对其他血管活性物质，如酒精、咖啡、香烟， 阿司匹林和布洛芬；3)母亲暴露于其他环境风险 因素，如其他药物、疾病和营养因素；以及4) 可能的基因和环境的相互作用。我们提出了一个额外的目标： 检查与减充血剂和香烟组合有关的HFM风险 使用。 病例将在26个大都市地区的三级护理机构确定 在美国和加拿大。控制措施将由病例婴儿的 主治医生(儿科医生或家庭医生)，并将组成下一名 案件发生后出生的三名婴儿。病例和对照的母亲将是 在案件确定之日起三个月内与 电话。标准化问卷详细询问人口统计情况 因素；生殖、内科和妊娠病史；用药情况； 行为(吸烟、饮酒、咖啡)和营养。在面试之前，每个人 母亲将收到一本带有颜色的药物识别手册 200多种非处方药咳嗽/感冒和止痛药的图片 召回怀孕早期使用的药物。的一个单独组件 研究将收集研究婴儿的口腔细胞样本，以及 他/她的父母。将拍摄标准化的照片，并 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例病例和825名对照(3名对照 每个案例)在数据收集后38个月内。案件的查明一直是 低于最初的预测，275例(即213例)中77%的病例将是 包括在研究的数据收集阶段结束时。延续 额外18个月的项目将允许额外的63个案例和228个 要包括的控件。因此，最初的目标病例数和对照数 都会被满足的。

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.