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Pulmonary Health in Children With Down Syndrome

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ClinicalTrials.gov Identifier: NCT04398862
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : June 7, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date May 18, 2020
First Posted Date May 21, 2020
Last Update Posted Date June 7, 2021
Actual Study Start Date August 21, 2020
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2020)
  • Total airway resistance [ Time Frame: Baseline ]
    Airway resistance (R5) measured using forced oscillation technique at 5 Hertz
  • Airway reactance [ Time Frame: Baseline ]
    Airway reactance (X5) measured using forced oscillation technique at 5 Hertz
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 18, 2020)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Health in Children With Down Syndrome
Official Title Measures of Pulmonary Health in Children With Down Syndrome
Brief Summary The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
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
Condition
  • Down Syndrome
  • Dysphagia, Oropharyngeal
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2020)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Allison Keck 720-777-6860 dsresearch@childrenscolorado.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04398862
Other Study ID Numbers 19-2092
R21HL151261-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Emily DeBoer, MD, MSCS University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2021