Pulmonary Health in Children With Down Syndrome

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

Official Title
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Measures of Pulmonary Health in Children With Down Syndrome

Conditions
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Down Syndrome, Dysphagia, Oropharyngeal

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with Down syndrome and aspiration<br>Outcomes will be compared between two groups although no intervention is submitted, this is an observational study. | |
| Children with Down syndrome without aspiration<br>Outcomes will be compared between two groups although no intervention is submitted, this is an observational study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total airway resistance after albuterol | Airway resistance (R5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol | Baseline | 
| Change in airway reactance after albuterol | Airway reactance (X5) measured using forced oscillation technique at 5 Hertz before and after administration of albuterol | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oscillometry, spirometry, outcomes