Assessing lung health in children with Down syndrome
Measures of Pulmonary Health in Children With Down Syndrome
This study is testing different ways to check lung health in children with Down syndrome, aged 3 to 18, to help find any problems and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04398862 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate various tests that can measure lung health in children diagnosed with Down syndrome. It focuses on children aged 3 to 18 years who are able to walk and have undergone a swallow study within the last five years. The study will utilize techniques such as oscillometry and spirometry to gather data on pulmonary function. By understanding lung health in this population, the study seeks to identify potential health issues and improve care strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 18 years with a diagnosis of Down syndrome who are able to walk.
Not a fit: Patients who are nonambulatory, have severe respiratory issues, or significant behavioral problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better assessment and management of lung health in children with Down syndrome.
How similar studies have performed: While this study focuses on a specific population, similar approaches in assessing lung health in children with other conditions have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Emily DeBoer, MD, MSCS — University of Colorado, Denver
- Study coordinator: Allison Keck
- Email: dsresearch@childrenscolorado.org
- Phone: 720-777-6860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.