Registry for measuring respiratory health in children

Measures of Respiratory Health Registry

This study is collecting information on lung health in children, especially those with cystic fibrosis and other breathing issues, to see how well a new testing method works compared to standard tests.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 0 Years to 99 Years
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05501587 on ClinicalTrials.gov

What this trial studies

This registry collects data on lung function in children, focusing on those with cystic fibrosis and other respiratory diseases. It utilizes the multiple breath washout (MBW) system alongside traditional pulmonary function tests to gather comprehensive data. The goal is to establish a normal range for small airways function in healthy children and validate MBW technology for clinical use. Data collected will include demographic and clinical information to support future analyses.

Who should consider this trial

Good fit: Ideal candidates include children diagnosed with cystic fibrosis or other physician-diagnosed lung diseases.

Not a fit: Patients with respiratory distress or those requiring supplementary oxygen may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding and management of respiratory diseases in children, particularly cystic fibrosis.

How similar studies have performed: Other studies utilizing similar pulmonary function testing approaches have shown promise, but the specific application of MBW in this context is relatively novel.

Eligibility criteria

Participants with CF

Inclusion Criteria:

-Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).

ii. A documented genotype with two disease-causing mutations in the CFTR gene.

\- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion Criteria:

* Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
* Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Participants with other Respiratory Disease

Inclusion criteria:

* Physician-diagnosed lung disease
* Informed consent by participant, parent, or legal guardian
* In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion criteria

* Physical findings at screening that would compromise the safety of the participant or the quality of the research data
* Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Healthy Participants

* Inclusion criteria
* Informed consent by participant, parent, or legal guardian
* In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Exclusion criteria

* Physical findings at screening that would compromise the safety of the participant or the quality of the research data
* Evidence of lung disease

Where this trial is running

Vancouver, British Columbia

• British Columbia Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Jonathan Rayment, MDCM, MSc — University of British Columbia
• Study coordinator: Rodrigo Sandoval, MSc

Conditions Respiratory Disease; Cystic Fibrosis