LUNG FUNCTION MEASURES IN PRESCHOOL CHILDREN WITH CYSTIC FIBROSIS

患有囊性纤维化的学龄前儿童的肺功能测量

• 批准号: 7603572
• 负责人: Margaret Rosenfeld
• 金额: $ 0.1万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603572
• 关键词: Awareness; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Data; Enrollment; Equipment; Funding; Grant; Human Resources; Institution; Investigation; Life; Measures; Nursery Schools; Oscillometry; Outcome Measure; Population; Procedures; Pulmonary Cystic Fibrosis; Pulmonary function tests; Quality Control; Research; Research Personnel; Resources; Respiratory physiology; Site; Source; Spirometry; Symptoms; Testing; Training; United States National Institutes of Health; aged; children with cystic fibrosis; cystic fibrosis patients; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. With the awareness that cystic fibrosis (CF) lung disease begins early in life and often prior to the onset of symptoms, there is increasing recognition of the need for multicenter clinical trials in young CF patients. Unfortunately, clinical investigations in this critical young population have been hindered by the lack of appropriate outcome measures, particularly measures of lung function. The proposed study is a prospective, longitudinal, descriptive, multi-center investigation of three promising lung function measures (spirometry, inductance plethymography (IP) and forced oscillometry (FO)) in preschool aged children with CF and in healthy control subjects, with the objective of assessing their utility as outcome measures for clinical trials in preschool CF patients. The study will utilize standardized equipment and testing procedures, rigorous training of study personnel, and ongoing quality control review of all primary data by an expert panel. In order to gain and document the required expertise in preschool lung function testing, each site will enroll preschool subjects without CF in a separate ¿certification protocol¿ prior to enrolling any subjects in the preschool lung function study.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 随着人们认识到囊性纤维化 (CF) 肺病在生命早期且通常在症状出现之前就开始出现，人们越来越认识到需要在年轻 CF 患者中进行多中心临床试验。由于缺乏适当的结果测量，特别是肺功能的测量，这项研究是对三种有前景的肺功能测量（肺活量测定、电感体积描记法（IP）和强迫振荡测量）的前瞻性、纵向、描述性、多中心研究。 (FO)) 在患有 CF 的学龄前儿童和健康对照受试者中进行，目的是评估其作为学龄前 CF 患者临床试验结果指标的效用。该研究将利用标准化设备和测试程序，对研究人员进行严格培训，专家小组对所有主要数据进行持续的质量控制审查，为了获得并记录学前肺功能测试所需的专业知识，每个站点将在单独的 ¿ 中招收没有 CF 的学前受试者。认证协议¿在将任何受试者纳入学前肺功能研究之前。