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
  Purpose

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
Chronic Lung Disease
Procedure: Infant Pulmonary Function Tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Pulmonary Function in Dysphagic Infants

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • infant pulmonary function test results [ Time Frame: On admission to study and 6 months later ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831038

Locations
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
Investigators
Principal Investigator: James D Tutor, MD Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
  More Information

No publications provided

Responsible Party: James D. Tutor, M.D., University of Tennessee
ClinicalTrials.gov Identifier: NCT00831038     History of Changes
Other Study ID Numbers: IRB#8819
Study First Received: January 27, 2009
Last Updated: November 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
pulmonary function tests
infants
chronic lung disease
dysphagia
chronic aspiration

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014