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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。由于缺乏敏感且可重复的结果指标，对囊性纤维化（CF）婴儿进行临床试验受到阻碍。最近，已经开发了用于婴儿肺功能测试（PFT）的新技术。这些技术有可能大大提高对CF肺病早期自然史和病理生理学的理解，并作为临床试验的可重复结果指标。在目前的研究中，肺功能的变化将在一个队列的婴儿CF，利用新的和传统的方法婴儿PFT的特点。9家参与临床试验机构将各入组10 - 15例受试者。每例受试者将在入组时以及入组后1个月、6个月和12个月接受检测。这项研究的目的是检验新的PFT技术产生的测量结果将作为CF婴儿临床试验的有用结果测量的假设。

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.