Pulmonary Health in Children With Down Syndrome

Measures of Pulmonary Health in Children With Down Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome; Dysphagia, Oropharyngeal

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Allison Keck; Phone Number: 720-777-6860; Email: dsresearch@childrenscolorado.org
• Study Contact Backup: Name: Rawan Jarrar

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Emily DeBoer, MD; Phone Number: 720-777-4953; Email: emily.deboer@childrenscolorado.org
      • Contact: Kate Smith, PhD; Phone Number: 720-777-6181; Email: Kate.h.smith@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 3-18 years (inclusive) with a diagnosis of Down syndrome who have had a swallow study in the previous 5 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total airway resistance	Airway resistance (R5) measured using forced oscillation technique at 5 Hertz	Baseline
Airway reactance	Airway reactance (X5) measured using forced oscillation technique at 5 Hertz	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in airway reactance after albuterol	Airway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol	Baseline
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Emily DeBoer, MD, MSCS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: spirometry; outcomes; oscillometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Gastrointestinal Diseases; Genetic Diseases, Inborn; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Deglutition Disorders; Down Syndrome
• Other Study ID Numbers: 19-2092; R21HL151261-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No