A Pilot Study of Pulmonary Function in Dysphagic Infants
Primary Purpose
Chronic Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infant Pulmonary Function Tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Lung Disease focused on measuring pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration
Eligibility 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
Sites / Locations
- LeBonheur Children's Medical Center
Outcomes
Primary Outcome Measures
infant pulmonary function test results
Secondary Outcome Measures
Full Information
NCT ID
NCT00831038
First Posted
January 27, 2009
Last Updated
November 28, 2011
Sponsor
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT00831038
Brief Title
A Pilot Study of Pulmonary Function in Dysphagic Infants
Official Title
A Pilot Study of Pulmonary Function in Dysphagic Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lung Disease
Keywords
pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Infant Pulmonary Function Tests
Intervention Description
Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.
Primary Outcome Measure Information:
Title
infant pulmonary function test results
Time Frame
On admission to study and 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Tutor, MD
Organizational Affiliation
Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
LeBonheur Children's Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
12. IPD Sharing Statement
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A Pilot Study of Pulmonary Function in Dysphagic Infants
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