Pulmonary Health in Children With Down Syndrome

Recruiting

• Conditions: Dysphagia, Oropharyngeal; Down Syndrome

• Registration Number: NCT04398862
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Study Start: 2020-08-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Airway reactance	Baseline	Airway reactance (X5) measured using forced oscillation technique at 5 Hertz
Total airway resistance	Baseline	Airway resistance (R5) measured using forced oscillation technique at 5 Hertz

Secondary Outcome Measures

Name	Time	Method
Change in airway reactance after albuterol	Baseline	Airway 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 Inventory	Baseline	The 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.
Change in total airway resistance after albuterol	Baseline	Airway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States