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MEASURES OF PULMONARY MORBIDITY IN CHILDREN WITH DOWN SYNDROME

Primary Objective

Aim 1: Primary outcome measures include lung function measurements from oscillometry and spirometry, change in oscillometry and spirometry measurements after bronchodilator is given, and results from a Six-Minute Walk test. Aim 2: Primary outcome measures are absolute neutrophil count and C-reactive protein in blood. Secondary outcomes to identify an atopic asthma phenotype include eosinophil count, total IgE, allergen specific IgE, and fractional exhaled nitric oxide. Assessment for nicotine exposure via blood cotinine is additional secondary outcome. Aim 3: Primary outcomes are respiratory symptom and quality of life assessments obtained by questionnaires.

Study category: Pediatrics

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Description

This study plans to learn more about lung health in children with Down syndrome. Sometimes children with Down syndrome breathe food or liquids into their lungs, which is called aspiration. We want to learn more about how aspiration affects the lungs and quality of life of children with Down syndrome. This will help us develop new treatments to protect the lungs. If you join the study, your child will participate in one or two study visits at Children's Hospital Colorado at Anschutz Medical Campus. The study procedures will take about 3 hours total, but can be spaced out to occur before, during, or after regular clinic appointments, or at a research-only visit. All of the study visit procedures are for research only. All of the study visit procedures are routinely performed in clinical care of children. The procedures include six-minute walk test, breathing test called oscillometry, exhaled nitric oxide test, and a blood draw.

Details
Age

Child

Eligibility

-Children ages 3 to 18 years old -Diagnosis of Down Syndrome/Trisomy 21 or mosaicism -Able to walk -Has had a swallow study (videofluoroscopic swallow study or fiberoptic endoscopic evaluation of swalling) performed within the past two years

Type of Study

Outcomes Research

Scope

Local

Location

Childrens Hospital Colorado

Principal Investigator
Emily Deboer,  MD

Emily Deboer, MD

Study ID

Protocol Number: 19-2092

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