ASTHMA PREGNANCY STUDY

哮喘妊娠研究

基本信息

批准号：
9332176
负责人：
Seth Sherman
金额：
$ 32.51万
依托单位：
THE EMMES COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-11 至 2017-08-15
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9332176
关键词：
Accounting Air Alabama Asthma Blood Pressure Breathing Cells Chronic Disease Clinic Clinic Visits Clinical Clinical Data Clinical assessments Cohort Studies Complication Data Collection Discipline of obstetrics Emergency Situation Environmental Risk Factor Epidemiology Exhalation Exposure to Flow Cytometry Genetic Hospitalization Hypersensitivity Immune Inflammation Intake Literature Lung Inflammation Mediation Medical Records Minimal Risk Study National Heart, Lung, and Blood Institute Nitric Oxide Patients Pharmaceutical Preparations Population Postpartum Period Pregnancy Prevention Research Procedures Protocols documentation Pulmonary Function Test/Forced Expiratory Volume 1 Pulse Oximetry Questionnaires Recording of previous events Recruitment Activity Regulatory T-Lymphocyte Reporting Respiratory physiology Risk Risk Factors Role Severities Specimen Surveys Symptoms Universities Visit Woman asthmatic atopy base dietary antioxidant experience improved inflammatory marker interest neonatal outcome pregnancy immunology prenatal statistics

项目摘要

The Division of Epidemiology, Statistics and Prevention Research (hereafter, the Division) The B-WELL-Mom clinical centers, Northwestern University and the University of Alabama Birmingham, will recruit a total of 400 asthmatics (200 with well-controlled asthma and 200 with sub-optimal asthma control) and 150 women without asthma from their prenatal clinic populations. Asthma control assessment will be based on the criteria described in the NHLBI expert panel report. Except for asthma history questions, control subjects follow the same protocol. All patients will have four study clinic visits. At each visit, clinical assessments will include blood pressure, pulse oximetry, peak flow, FEV1 and FEV6. Biologic specimens will also be collected. Patients complete questionnaires related to symptoms and risk factors for exacerbation or mediation of asthma or breathing problems. Flow cytometry will be conducted to count immune cells including T-regulatory cells. All of the clinical data collection procedures are well-established procedures with minimal risk and the study surveys are based on preexisting, validated questionnaires. Between clinic visits, women will record their peak flow, exhaled nitric oxide and answer questions on symptoms, medications and other factors that might interfere with breathing. Medical record review will capture emergency visits and hospitalizations as well as details of labor and delivery. Supports Z1AHD008936

流行病学，统计和预防研究（以下简称该部） B-Well-Mom临床中心，西北大学和阿拉巴马大学伯明翰大学将招募400次哮喘患者（200例患有良好控制的哮喘和200个具有亚最佳哮喘控制的哮喘）和150名没有产前诊所哮喘的女性。哮喘控制评估将基于NHLBI专家小组报告中描述的标准。除了哮喘历史问题，控制对象遵循相同的协议。所有患者将进行四次研究诊所就诊。每次访问时，临床评估将包括血压，脉搏血氧仪，峰流量，FEV1和FEV6。还将收集生物标本。患者填写与症状和危险因素有关的调查表，以加剧哮喘或呼吸问题。流式细胞仪将进行计数以计算包括T调节细胞在内的免疫细胞。所有临床数据收集程序都是具有最小风险的完善程序，研究调查基于先前存在的，经过验证的问卷。在诊所就诊之间，妇女将记录其峰值流量，呼出一氧化氮，并回答有关可能干扰呼吸的症状，药物和其他因素的问题。病历审查将捕获紧急就诊和住院以及人工和分娩的详细信息。支持Z1AHD008936