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Pulmonary Health in Children With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398862
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease
Down Syndrome Dysphagia, Oropharyngeal

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measures of Pulmonary Health in Children With Down Syndrome
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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.



Primary Outcome Measures :
  1. Total airway resistance [ Time Frame: Baseline ]
    Airway resistance (R5) measured using forced oscillation technique at 5 Hertz

  2. Airway reactance [ Time Frame: Baseline ]
    Airway reactance (X5) measured using forced oscillation technique at 5 Hertz


Secondary Outcome Measures :
  1. Change in total airway resistance after albuterol [ Time Frame: Baseline ]
    Airway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol

  2. Change in airway reactance after albuterol [ Time Frame: Baseline ]
    Airway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol

  3. Health-related quality of life, as measured by the Pediatric Quality of Life Inventory [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 2 years
Criteria

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 2 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398862


Contacts
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Contact: Jacky Nevarez, BA 720-777-6860 dsresearch@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Contact: Emily DeBoer, MD    720-777-4953    emily.deboer@childrenscolorado.org   
Contact: Kate Smith, PhD    720-777-6181    Kate.h.smith@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Emily DeBoer, MD, MSCS University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04398862    
Other Study ID Numbers: 19-2092
R21HL151261-01 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
oscillometry
spirometry
outcomes
Additional relevant MeSH terms:
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Deglutition Disorders
Down Syndrome
Syndrome
Disease
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn