Measures of Pulmonary Health in Children With Down Syndrome

University of Colorado, Denver1 site in 1 country75 target enrollmentAugust 21, 2020

Overview

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

Registry

clinicaltrials.gov

Start Date

August 21, 2020

End Date

December 30, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

Airway reactance

Time Frame: Baseline

Airway reactance (X5) measured using forced oscillation technique at 5 Hertz

Total airway resistance

Time Frame: Baseline

Airway resistance (R5) measured using forced oscillation technique at 5 Hertz

Change in airway reactance after albuterol(Baseline)
Health-related quality of life, as measured by the Pediatric Quality of Life Inventory(Baseline)
Change in total airway resistance after albuterol(Baseline)