Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls.
II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.
Detailed Description
PROTOCOL OUTLINE: Patients and healthy controls receive an oral dose of doubly labeled water following initial urine collection on day 1. Patients undergo additional urine collection at 4-6 hours following doubly labeled water consumption and then daily for 7 days.
Additionally, at the beginning of the study, patients and healthy controls undergo respiratory calorimetry over approximately 45 minutes at rest, starting approximately 2-3 hours after the last meal consumption and last use of aerosol bronchodilators (if required).
Study Design
- Study Type
- Observational
- Observational Model
- Natural History
Eligibility Criteria
- Ages
- 0 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided