EVALUATION OF PULMONARY FUNCTION TESTS FOR OUTCOME MEASURES IN INFANT WITH CF

患有 CF 的婴儿的肺功能测试结果评估

• 批准号: 7603516
• 负责人: Margaret Rosenfeld
• 金额: $ 0.01万
• 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/7603516
• 关键词: Age; Breathing; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Devices; Evaluation; Funding; Future; Generations; Grant; Infant; Institution; Life; Lung; Lung diseases; Measurement; Measures; Outcome Measure; Pulmonary Cystic Fibrosis; Pulmonary function tests; Purpose; Range; Research; Research Personnel; Resources; Source; Spirometry; Symptoms; Techniques; Testing; Tidal Volume; Time; United States National Institutes of Health; early cystic fibrosis; expiration; improved; infancy; lung volume; respiratory

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. Recent studies have demonstrated that CF lung disease begins far earlier than previously understood, frequently in infancy and prior to the onset of respiratory symptoms. To date, research in this age range has been hindered by the lack of sensitive and reproducible measures of lung disease. Spirometry requires the voluntary generation of a maximal inspiratory effort followed by a rapid and maximal forced expiration. Because infants cannot perform such a maneuver, measurements in the first several years of life have been restricted to those obtained in the tidal volume (normal breathing) range, where they are highly variable and poorly reproducible. Recently, a new technique has been developed for measuring forced expiratory flows from raised lung volumes and fractional lung volumes in sedated infants, for the first time producing results comparable to those obtained by older subjects. These new techniques have the potential to dramatically improve the understanding of early CF lung disease, and to serve as reproducible outcome measures for clinical trials. Although these tests have been successfully employed in single-center studies utilizing investigator-fabricated devices, they have never been employed in a multi-center setting. The purpose of this study is to validate the Infant Pulmonary Lab device, manufactured by Collins, Inc., for use in future clinical trials and to determine whether infant pulmonary function testing with the IPL device is safe and well tolerated in infants with CF.

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH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 中心，不一定是研究者的机构。 最近的研究表明，CF肺病的发病时间比以前所了解的要早得多，通常发生在婴儿期和呼吸道症状发作之前。迄今为止，由于缺乏敏感和可重复的肺部疾病指标，该年龄段的研究受到阻碍。肺量测定法需要自主产生最大吸气努力，然后是快速和最大用力呼气。 由于婴儿不能进行这样的动作，在生命的最初几年的测量已被限制在潮气量（正常呼吸）范围内，在那里他们是高度可变的，重现性差。 最近，一种新的技术已经开发出来，用于测量用力呼气流量从提高肺容量和肺容量分数在镇静婴儿，第一次产生的结果与老年人所获得的。 这些新技术有可能大大提高对早期CF肺病的理解，并作为临床试验的可重复结果指标。 虽然这些测试已成功用于单中心研究，使用搅拌器制造的设备，他们从来没有被用于多中心设置。 本研究旨在确认由柯林斯公司生产的婴儿肺实验室设备，用于未来的临床试验，并确定使用IPL器械进行婴儿肺功能测试是否安全，CF婴儿是否耐受良好。