LUNG FUNCTION MEASURES IN PRESCHOOL CHILDREN WITH CYSTIC FIBROSIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 随着人们意识到囊性纤维化(CF)肺部疾病在生命早期就开始了，通常在症状出现之前，人们越来越认识到在年轻的CF患者中进行多中心临床试验的必要性。不幸的是，由于缺乏适当的结果测量，特别是肺功能测量，在这一关键的年轻人群中的临床研究一直受到阻碍。这项研究是一项前瞻性、纵向、描述性、多中心的研究，旨在评估三种有前景的肺功能指标(肺活量测定法、电感体积描记法(IP)和强迫振荡法(FO))在学龄前儿童CF患者和健康对照组中的有效性，目的是评估它们作为学龄前CF患者临床试验结果的有效性。这项研究将利用标准化的设备和测试程序，对研究人员进行严格的培训，并由专家小组对所有主要数据进行持续的质量控制审查。为了获得和记录学龄前肺功能测试所需的专业知识，在将任何受试者纳入学龄前肺功能研究之前，每个站点都将在一个单独的认证方案中招收无肺功能的学龄前受试者。

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.