Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography
NCT ID: NCT05455671
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2022-08-01
2024-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 - Healthy Controls
Persons, male or female, between the ages of 3 and 21 (inclusive) with healthy lungs, defined by no known or suspected chronic or temporary lung disease. A single study visit
No interventions assigned to this group
Cohort 2 - CF Longitudinal
Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of \>60mmol/L, between the ages of 3 and 21 (inclusive).
No interventions assigned to this group
Cohort 3 - CF Exacerbation
Persons, male or female, with CF, defined by two known disease-causing mutations and/or a sweat chloride value of \>60mmol/L, between the ages of 3 and 21 (inclusive), experiencing a pulmonary exacerbation requiring antibiotics.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 3-21 years
* Male or female
* Healthy subjects with no known or suspected chronic or temporary lung disease
Cohort 2:
* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value(\>60 mmol/L) or two known disease causing mutations
Cohort 3:
* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value (\>60 mmol/L) or two known disease causing mutations
* Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics
Exclusion Criteria
* Known congenital heart disease, arrhythmia, or history of heart failure
* Wearing a pacemaker or a metallic surgical implant in the chest
* History of infection with Burkholderia cepacia
* Developmental delays that could result in an inability to complete study procedures
3 Years
21 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jordana Jordana, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Other Identifiers
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22-0114
Identifier Type: -
Identifier Source: org_study_id