A Pilot Study of Pulmonary Function in Dysphagic Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00831038

Enrollment

Registered

2009-01-28

Start date

2008-08-31

Completion date

2011-06-30

Last updated

2011-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lung Disease

Keywords

pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration

Brief summary

Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.

Detailed description

Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed with dysphagia via a modified barium feeding study will be recruited into the study. The infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory. Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the primary care physicians. Six months later the infants will again be sedated and have pulmonary functions measured. Results of the two sets of tests will be compared statistically.

Interventions

PROCEDUREInfant Pulmonary Function Tests

Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 24 Months

Healthy volunteers

Yes

Inclusion criteria

* infants between ages 1-24 months who have been newly diagnosed with dysphagia

Exclusion criteria

* cystic fibrosis * obstructive sleep apnea * seizures * allergy or adverse reaction to chloral hydrate * heart disease * liver disease * kidney disease * pneumonia * pleural effusion * neuromuscular disease * major congenital anomalies * tracheoesophageal fistula * vascular ring * bronchopulmonary dysplasia * pharyngeal anomalies * Arnold-Chiari malformation

Design outcomes

Primary

Measure	Time frame
infant pulmonary function test results	On admission to study and 6 months later

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026