Down SyndromeNCT04398862
Pulmonary Health in Children With Down Syndrome
An observational study of Down Syndrome and Dysphagia, Oropharyngeal, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Down Syndrome, Dysphagia, Oropharyngeal
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Rawan Jarrar contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Emily DeBoer, MD, 720-777-4953, emily.deboer@childrenscolorado.org
Kate Smith, PhD, 720-777-6181, Kate.h.smith@cuanschutz.edu
About this study
Official title: 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.
- Conditions
- Down Syndrome, Dysphagia, Oropharyngeal
- Keywords
- oscillometry, spirometry, outcomes
- Medical subject headings
- Down Syndrome, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total airway resistance
Airway resistance (R5) measured using forced oscillation technique at 5 Hertz
Measured: Baseline
Airway reactance
Airway reactance (X5) measured using forced oscillation technique at 5 Hertz
Measured: Baseline
Secondary outcomes (3)
Change in total airway resistance after albuterol
Airway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol
Measured: Baseline
Change in airway reactance after albuterol
Airway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start21 Aug 2020
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Emily DeBoer, MD, MSCS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398862
- Sponsor's protocol ID
- 19-2092
- Other IDs
- R21HL151261-01
- Status last verified
- Jan 2024
- First submitted
- 18 May 2020
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measures of Pulmonary Health in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT04398862
- Acronym / sponsor ID
- 19-2092
- Conditions
- Down Syndrome, Dysphagia, Oropharyngeal
- Keywords
- oscillometry, spirometry, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to learn more about tests that can assess lung health in children with Down syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Change in total airway resistance after albuterol
Time frame: Baseline
Change in airway reactance after albuterol
Time frame: Baseline
Health-related quality of life, as measured by the Pediatric Quality of Life Inventory
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rawan Jarrar contact
Emily DeBoer, MD, MSCS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Dysphagia, Oropharyngeal, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison Keck (720-777-6860, dsresearch@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total airway resistance (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.