Pulmonary Health in Children With Down Syndrome

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Dysphagia, Oropharyngeal; Down Syndrome

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04398862

19-2092

R21HL151261-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 75 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

Children with Down syndrome and aspiration

Description:

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

Children with Down syndrome without aspiration

Description:

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