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Clinical Trials/NCT00831038
NCT00831038
Completed
Not Applicable

A Pilot Study of Pulmonary Function in Dysphagic Infants

University of Tennessee1 site in 1 country26 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Lung Disease
Sponsor
University of Tennessee
Enrollment
26
Locations
1
Primary Endpoint
infant pulmonary function test results
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

James D. Tutor, M.D.

James D. Tutor, M.D.

University of Tennessee

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • cystic fibrosis
  • obstructive sleep apnea
  • allergy or adverse reaction to chloral hydrate
  • heart disease
  • liver disease
  • kidney disease
  • pneumonia
  • pleural effusion
  • neuromuscular disease
  • major congenital anomalies

Outcomes

Primary Outcomes

infant pulmonary function test results

Time Frame: On admission to study and 6 months later

Study Sites (1)

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