A Pilot Study of Pulmonary Function in Dysphagic Infants

Not Applicable

Completed

• Conditions: Chronic Lung Disease

• Registration Number: NCT00831038
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-28
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
infant pulmonary function test results	On admission to study and 6 months later

Trial Locations

Locations (1)

LeBonheur Children's Medical Center; 🇺🇸 Memphis, Tennessee, United States