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A Pilot Study of Pulmonary Function in Dysphagic Infants

This study has been completed.
Sponsor:
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
James D. Tutor, M.D., University of Tennessee
ClinicalTrials.gov Identifier:
NCT00831038
First received: January 27, 2009
Last updated: November 28, 2011
Last verified: November 2011
History of Changes

January 27, 2009
November 28, 2011
August 2008
June 2011   (final data collection date for primary outcome measure)
infant pulmonary function test results [ Time Frame: On admission to study and 6 months later ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831038 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Study of Pulmonary Function in Dysphagic Infants
A Pilot Study of Pulmonary Function in Dysphagic Infants

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Lung Disease
Procedure: Infant Pulmonary Function Tests
Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
1 Month to 24 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831038
IRB#8819
No
James D. Tutor, M.D., University of Tennessee
University of Tennessee
University of Tennessee Health Science Center
Principal Investigator: James D Tutor, MD Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
University of Tennessee
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP