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NCT Number: NCT05501587

Measures of Respiratory Health Registry

There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.

Recruiting

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Key information

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location status: Recruiting

Location contact

Alam Lakhani

CONTACT

[email protected]

6048752345 ext. 7606

Jonathan Rayment, MDCM, MSc

PRINCIPAL_INVESTIGATOR

Rodrigo Sandoval, MSc

CONTACT

[email protected]

6048752345 ext. 2928

About this study

The scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (CF) and children with non-CF respiratory disease using the multiple breath washout (MBW) system. These data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (PFT) data. The MBW data will be collected with concurrent with clinically indicated PFT testing.

The purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in CF and non-CF respiratory disease.

Ultimately, the objective of this registry is to validate MBW technology as a tool that can be utilized in clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To validate new lung function testing technologies

    Time frame: 10 years

    The ultimate objective of this registry is to validate new lung function testing technologies as tools that can be utilized in clinical care.

Study contacts

Contact information is provided by the study sponsor or research team.

Alam Lakhani

CONTACT

[email protected]

6048752345 ext. 7606

Rodrigo Sandoval, MSc

CONTACT

[email protected]

6048752345 ext. 2928

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: MRH

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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