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Sponsors and Collaborators: |
University of Tennessee University of Tennessee Health Science Center |
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Information provided by: | University of Tennessee |
ClinicalTrials.gov Identifier: | NCT00831038 |
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.
Condition | Intervention |
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Chronic Lung Disease |
Procedure: Infant Pulmonary Function Tests |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Pilot Study of Pulmonary Function in Dysphagic Infants |
Estimated Enrollment: | 25 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 1 Month to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: James D Tutor, MD | 901-287-5222 | jtutor@utmem.edu |
Contact: Barbara Culbreath, RN, BSN, CCRC | 901-287-5351 | bculbreath@utmem.edu |
United States, Tennessee | |
LeBonheur Children's Medical Center | Recruiting |
Memphis, Tennessee, United States, 38103 | |
Contact: James D Tutor, MD 901-287-5222 jtutor@utmem.edu | |
Contact: Barbara Culbreath, RN, BSN CCRC 901-287-5351 bculbreath@lebonheur.org | |
Principal Investigator: James D Tutor, MD | |
Sub-Investigator: Robert A Schoumacher, MD | |
Sub-Investigator: Saumini Srinivasin, MD | |
Sub-Investigator: Dennis C Stokes, MD | |
Sub-Investigator: Mike Christensen, Ph.D | |
Sub-Investigator: Barbara Culbreath, RN, BSN, CCRC |
Principal Investigator: | James D Tutor, MD | Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine |
Responsible Party: | Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine ( James D. Tutor, M.D. ) |
Study ID Numbers: | IRB#8819 |
Study First Received: | January 27, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00831038 History of Changes |
Health Authority: | United States: Institutional Review Board |
pulmonary function tests infants chronic lung disease dysphagia chronic aspiration |
Deglutition Disorders Respiratory Tract Diseases Lung Diseases |
Respiratory Tract Diseases Lung Diseases |