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A Pilot Study of Pulmonary Function in Dysphagic Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00831038
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : November 30, 2011
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Lung Disease Procedure: Infant Pulmonary Function Tests

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Pulmonary Function in Dysphagic Infants
Study Start Date : August 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: Infant Pulmonary Function Tests
    Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.

Outcome Measures

Primary Outcome Measures :
  1. infant pulmonary function test results [ Time Frame: On admission to study and 6 months later ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831038

United States, Tennessee
LeBonheur Children's Medical Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
University of Tennessee
University of Tennessee Health Science Center
Principal Investigator: James D Tutor, MD Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
More Information

Responsible Party: James D. Tutor, M.D., University of Tennessee
ClinicalTrials.gov Identifier: NCT00831038     History of Changes
Other Study ID Numbers: IRB#8819
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011

Keywords provided by James D. Tutor, M.D., University of Tennessee:
pulmonary function tests
chronic lung disease
chronic aspiration

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases