Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04398862

Conditions

Down Syndrome

Dysphagia, Oropharyngeal

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Down Syndrome

Dysphagia, Oropharyngeal

Study ID

NCT04398862

Start date

Aug 21, 2020

Status verified date

Jan, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Total airway resistance [ Time Frame: Baseline ]
  • Airway reactance [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Allison Keck

720-777-6860dsresearch@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily DeBoer, MD

720-777-4953emily.deboer@childrenscolorado.org

Kate Smith, PhD

720-777-6181Kate.h.smith@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 26, 2024

Last verified

Jan, 2024

Keywords

  • oscillometry
  • spirometry
  • outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-01-26.