EVALUATION OF PULMONARY FUNCTION TESTS FROM RAISED LUNG VOLUMES AS OUTCOME MEAS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。由于缺乏敏感和可重复的结果指标，囊性纤维化(CF)婴儿的临床试验一直受到阻碍。近年来，针对婴幼儿肺功能(PFT)检测的新技术不断涌现。这些技术有可能极大地提高对CF肺部疾病早期自然病史和病理生理学的了解，并作为临床试验的可重复性结果指标。在目前的研究中，将利用新的和传统的婴儿肺功能测试方法，对一组患有CF的婴儿的肺功能变化进行表征。9个参与地点将各招收10至15个科目。每个科目都将在注册时以及注册后1、6和12个月进行测试。这项拟议研究的目的是检验这样一种假设，即新的PFT技术产生的测量结果将作为CF型婴儿临床试验的有用结果指标。

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. The conduct of clinical trials in infants with cystic fibrosis (CF) has been hindered by the lack of sensitive and reproducible outcome measures. Recently, new techniques have been developed for pulmonary function testing (PFT) in infants. These techniques have the potential to dramatically improve the understanding of the early natural history and pathophysiology of CF lung disease, and serve as reproducible outcome measures for clinical trials. In the current study, changes in pulmonary function will be characterized in a cohort of infants with CF, utilizing both new and conventional methods of infant PFTs. Ten to 15 subjects will be enrolled at each of 9 participating sites. Each subject will undergo testing at enrollment and 1, 6, and 12 months after enrollment. The goal of the proposed study is to test the hypothesis that measurements produced by the new PFT techniques will serve as useful outcome measures for clinical trials in infants with CF.