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Pulmonary Health in Children With Down Syndrome

Measures of Pulmonary Health in Children With Down Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04398862
Enrollment
75
Registered
2020-05-21
Start date
2020-08-21
Completion date
2024-12-30
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Dysphagia, Oropharyngeal

Keywords

oscillometry, spirometry, outcomes

Brief summary

The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total airway resistanceBaselineAirway resistance (R5) measured using forced oscillation technique at 5 Hertz
Airway reactanceBaselineAirway reactance (X5) measured using forced oscillation technique at 5 Hertz

Secondary

MeasureTime frameDescription
Change in total airway resistance after albuterolBaselineAirway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol
Change in airway reactance after albuterolBaselineAirway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol
Health-related quality of life, as measured by the Pediatric Quality of Life InventoryBaselineThe Pediatric Quality of Life Inventory (PedsQL) assesses four domains of quality of life. Results are converted to a score from 0-100, where low numbers are low quality of life and higher numbers is better quality of life.

Countries

United States

Contacts

Primary ContactAllison Keck
dsresearch@childrenscolorado.org720-777-6860
Backup ContactRawan Jarrar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026