Pulmonary Health in Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:

Measures of Pulmonary Health in Children With Down Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398862
• Other study ID #: 19-2092
• Secondary ID: R21HL151261-01
• Status: Recruiting
• Start date: August 21, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Allison Keck
• Phone: 720-777-6860
• Email: dsresearch[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Down Syndrome
• Dysphagia, Oropharyngeal
• Syndrome

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total airway resistance	Airway resistance (R5) measured using forced oscillation technique at 5 Hertz	Baseline
Primary	Airway reactance	Airway reactance (X5) measured using forced oscillation technique at 5 Hertz	Baseline
Secondary	Change in total airway resistance after albuterol	Airway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol	Baseline
Secondary	Change in airway reactance after albuterol	Airway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol	Baseline
Secondary	Health-related quality of life, as measured by the Pediatric Quality of Life Inventory	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.	Baseline