Pulmonary Health in Children With Down Syndrome

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04398862

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

36.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome Dysphagia, Oropharyngeal

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Measures of Pulmonary Health in Children With Down Syndrome

Actual Study Start Date :

Aug 21, 2020

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Children with Down syndrome and aspiration Outcomes will be compared between two groups although no intervention is submitted, this is an observational study.
Children with Down syndrome without aspiration Outcomes will be compared between two groups although no intervention is submitted, this is an observational study.

Outcome Measures

Primary Outcome Measures

Total airway resistance [Baseline]
Airway resistance (R5) measured using forced oscillation technique at 5 Hertz
Airway reactance [Baseline]
Airway reactance (X5) measured using forced oscillation technique at 5 Hertz

Secondary Outcome Measures

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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