- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00831038
A Pilot Study of Pulmonary Function in Dysphagic Infants
November 28, 2011 updated by: James D. Tutor, M.D., University of Tennessee
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38103
- LeBonheur Children's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
infant pulmonary function test results
Time Frame: On admission to study and 6 months later
|
On admission to study and 6 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James D Tutor, MD, Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 27, 2009
First Submitted That Met QC Criteria
January 27, 2009
First Posted (Estimate)
January 28, 2009
Study Record Updates
Last Update Posted (Estimate)
November 30, 2011
Last Update Submitted That Met QC Criteria
November 28, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#8819
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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