Pulmonary Health in Children With Down Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-21

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Maternal Smoking On Neonatal Lung Function

NCT00005285

Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease

COMPLETED

Prospective Evaluation of Airways Reactivity

NCT00005282

Lung Diseases Asthma Lung Diseases, Obstructive +1 more

COMPLETED

PRospective Observational Multicentre Study on VAriability of Lung Function in Stable PCD Patients

NCT03704896

Primary Ciliary Dyskinesia

UNKNOWN

Epidemiology of Airway Responsiveness

NCT00005284

Asthma Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease

COMPLETED

Exercise-induced Bronchoconstriction Diagnostics: Impact of a Repeated Exercise Challenge Test

NCT01214551

Exercise Induced Bronchoconstriction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Down Syndrome Dysphagia, Oropharyngeal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children with Down syndrome and aspiration

Outcomes will be compared between two groups although no intervention is submitted, this is an observational study.

No interventions assigned to this group

Children with Down syndrome without aspiration

Outcomes will be compared between two groups although no intervention is submitted, this is an observational study.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No