PULM FUNCTION TESTS FROM RAISED LUNG VOLUMES AS OUTCOME IN INFANTS WITH CF

以肺活量升高作为 CF 婴儿的结果的脉搏功能测试

• 批准号: 7605065
• 负责人: GWENDOLYN S KERBY
• 金额: $ 0.07万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605065
• 关键词: Child; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Conduct Clinical Trials; Enrollment; Ensure; Functional disorder; Funding; Goals; Gold; Grant; Infant; Institution; Life; Measurement; Measures; Natural History; Obstructive Lung Diseases; Outcome; Outcome Measure; Pulmonary Cystic Fibrosis; Pulmonary function tests; Range; Research; Research Personnel; Resources; Schedule; Source; Spirometry; Standards of Weights and Measures; Techniques; Testing; Tidal Volume; Time; United States National Institutes of Health; Visit; day; experience; improved; lung volume

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 CF has been hindered by the lack of sensitive and reproducible outcome measures. In older subjects, spirometry is the gold standard for quantifying obstructive lung disease. Because infants cannot perform such a maneuver, measurements in the first several years of life have been restricted to expiratory flows obtained in the tidal volume range, where they are highly variable and poorly reproducible. Recently, techniques have been developed for measuring forced expiratory flows from raised lung volumes in infants and young children, for the first time producing flow-volume curves in infants comparable to those obtained by spirometry in older subjects. These new 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. Each subject will undergo testing at enrollment (Visit 1), 6 months and 12 months after enrollment (Visits 2 and 3), and at a study visit to be scheduled one month after visit 1 (the One-Month Reliability Visit). To ensure that subjects are not experiencing an intercurrent illness, testing at 6 and 12 months after enrollment may be carried out up to one month before or after each of these scheduled visits. The One Month Reliability Visit should be scheduled 28 to 35 days after Visit 1 (Month 0). If testing in that time frame is not feasible, the One-Month Reliability Visit may be re-scheduled 28 to 35 days before or after Visit 2 or 3 The goal of the proposed study is to test the hypothesis that measurements of fractional lung volumes and forced expiratory flows generated by the new raised volume pulmonary function testing technique will serve as useful outcome measures for clinical trials in infants with CF.

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。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 由于缺乏敏感且可重复的结果测量，CF 婴儿的临床试验的进行受到阻碍。对于老年受试者，肺活量测定是量化阻塞性肺病的金标准。由于婴儿无法执行此类操作，因此生命最初几年的测量仅限于潮气量范围内获得的呼气流量，该流量变化很大且可重复性差。 最近，已经开发出用于测量婴儿和幼儿肺容量增加的用力呼气流量的技术，首次产生了与老年受试者通过肺活量测定获得的流量曲线相当的婴儿流量曲线。这些新技术有可能显着提高对 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测量。 每个受试者将在入组时（访视 1）、入组后 6 个月和 12 个月（访视 2 和 3）以及在访视 1 后一个月安排的研究访视（一个月可靠性访视）接受测试。为了确保受试者没有并发疾病，可以在每次预定就诊之前或之后最多一个月进行入组后 6 个月和 12 个月的测试。 一个月可靠性访问应安排在访问 1（第 0 个月）后 28 至 35 天。如果在该时间范围内进行测试不可行，则可以在第 2 次或第 3 次访视之前或之后 28 至 35 天重新安排一个月的可靠性访视。拟议研究的目标是检验以下假设：肺容量分数的测量值和由新的增加容量肺功能测试技术产生的用力呼气流量将作为 CF 婴儿临床试验的有用结果测量。