Pulmonary Health in Children With Down Syndrome

NCT04398862 | Unknown

• 2 other identifiers: 19-2092R21HL151261-01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

oscillometry; spirometry; outcomes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in total airway resistance after albuterol

  Baseline

• Change in airway reactance after albuterol

  Baseline

• Health-related quality of life, as measured by the Pediatric Quality of Life Inventory

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Down Syndrome; Deglutition Disorders

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Emily DeBoer, MD, MSCS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Keck

CONTACT

720-777-6860; dsresearch@childrenscolorado.org

Rawan Jarrar

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: August 21, 2020
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)