Status:
RECRUITING
Pulmonary Health in Children With Down Syndrome
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Down Syndrome
Dysphagia, Oropharyngeal
Eligibility:
All Genders
3-18 years
Brief Summary
The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.
Eligibility Criteria
Inclusion
- Children aged 3 to 18 years, inclusive, at time of consent
- Diagnosis of Down syndrome/trisomy 21 or mosaicism
- Able to walk
- Had a swallow study (video fluoroscopic swallow study or fiberoptic endoscopic evaluation of swallowing) performed within 5 years of consent date
Exclusion
- Pregnant or lactating
- Nonambulatory
- Have a tracheostomy or other known severe glottic or subglottic obstruction that would significantly affect the results of testing
- Have a significant acute respiratory illness, defined as treatment with steroids, antibiotics, or an increase in supplemental oxygen
- have a medical illness that would a)increase the risk the participate would incur by participating in the study, b) interfere with the outcomes of the study, or c) interfere with the performance of study participants
- Have a severe behavioral problem that would interfere with the performance of study procedures
Key Trial Info
Start Date :
August 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04398862
Start Date
August 21 2020
End Date
December 30 2024
Last Update
January 26 2024
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045