LUNG FUNCTION MEASURES IN PRESCHOOL CHILDREN WITH CYSTIC FIBROSIS

患有囊性纤维化的学龄前儿童的肺功能测量

• 批准号: 7603572
• 负责人: Margaret Rosenfeld
• 金额: $ 0.1万
• 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/7603572
• 关键词: Awareness; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cystic Fibrosis; Data; Enrollment; Equipment; Funding; Grant; Human Resources; Institution; Investigation; Life; Measures; Nursery Schools; Oscillometry; Outcome Measure; Population; Procedures; Pulmonary Cystic Fibrosis; Pulmonary function tests; Quality Control; Research; Research Personnel; Resources; Respiratory physiology; Site; Source; Spirometry; Symptoms; Testing; Training; United States National Institutes of Health; aged; children with cystic fibrosis; cystic fibrosis patients; prospective

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.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 随着人们对囊性纤维化（CF）肺部疾病的意识在生命的早期开始，通常是在症状发作之前，人们对年轻CF患者进行多中心临床试验的需求越来越多。不幸的是，由于缺乏适当的结局指标，尤其是肺功能的测量，这使这一关键年轻人口的临床研究受到了阻碍。拟议的研究是三个承诺肺功能测量值（肺活量测量，电感多摄影学（IP）和强制振荡法（FO）的前瞻性，纵向，描述性，多中心投资，用于CF和健康对照受试者中的学龄前儿童中的振动仪（FO），目的是评估其作为临床临床训练患者的效用，并将其目的评估为临床训练患者。该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培训以及专家小组对所有主要数据的持续质量控制审查。为了获得和记录学龄前肺功能测试中所需的专业知识，每个站点将在没有CF的情况下注册学龄前学科，然后在读取学龄前儿童肺功能研究中注册任何受试者之前，将其注册为单独的认证协议。