# Identifying Measures of Pulmonary Morbidity for Clinical Trials in Children with Down Syndrome and Aspiration

> **NIH NIH R21** · UNIVERSITY OF COLORADO DENVER · 2020 · $157,500

## Abstract

Respiratory disease is the most common cause of death in people with Down syndrome. Children with Down
syndrome have a high risk of aspiration, and chronic aspiration can lead to respiratory diseases including
pneumonitis, pneumonia, and bronchiectasis. Epidemiological studies in children without Down syndrome have
shown that respiratory health in childhood is a strong predictor of respiratory health across the lifespan, with
trajectories of lung health established by age 6 years. However, little is known about lung health trajectories in
DS or how aspiration and lung disease in childhood leads to morbidity in Down syndrome across the lifespan.
To improve respiratory health over the lifespan, this study aims to determine the effect of aspiration on lung
function and inflammation in children with Down syndrome. This study is a case-control evaluation of children
with Down syndrome who aspirate and those who do not aspirate. The overarching goal of this project is to
identify quantifiable measures of pulmonary morbidity that can be used as outcome measures in clinical trials
designed to treat and prevent aspiration in children with DS. This will be tested through AIM 1: Determine the
effect of aspiration on lung function measured by oscillometry and spirometry with bronchodilator response and
by six-minute walk in children with Down syndrome, and AIM 2: Determine the effect of aspiration on
inflammatory blood markers in children with DS. AIM 3: Determine the effect of aspiration on caregiver-reported
respiratory symptoms and quality of life. The hypothesis is that aspiration causes measurable changes in lung
function, inflammatory markers, and caregiver-reported symptom and quality of life outcomes distinct from
asthma in children with DS. The study will include 75 children between 3 and 18 years with DS who have had a
clinical swallow study diagnosing aspiration or no aspiration. The lung function, respiratory symptom, and quality
of life assessments will be repeated after 3-12 months for a subset of 40 participants. The proposed study will
characterize objective lung function and airway inflammation measurements in children with DS. Establishing
these measures for participant identification and clinical outcomes will enable the design of clinical trials that test
treatments to diminish the effects of aspiration on lung function and inflammation and reduce respiratory disease
in children with DS, which will improve respiratory health across their lifespan.

## Key facts

- **NIH application ID:** 10020429
- **Project number:** 5R21HL151261-02
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Emily M DeBoer
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $157,500
- **Award type:** 5
- **Project period:** 2019-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020429

## Citation

> US National Institutes of Health, RePORTER application 10020429, Identifying Measures of Pulmonary Morbidity for Clinical Trials in Children with Down Syndrome and Aspiration (5R21HL151261-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10020429. Licensed CC0.

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