A Pilot Study of Pulmonary Function in Dysphagic Infants

This study is currently recruiting participants.

Verified by University of Tennessee, January 2009

First Received: January 27, 2009 Last Updated: January 29, 2009 History of Changes

Sponsors and Collaborators:	University of Tennessee University of Tennessee Health Science Center
Information provided by:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00831038

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:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
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 ]

Estimated Enrollment:	25
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: James D Tutor, MD	901-287-5222	jtutor@utmem.edu
Contact: Barbara Culbreath, RN, BSN, CCRC	901-287-5351	bculbreath@utmem.edu

Locations

United States, Tennessee
LeBonheur Children's Medical Center	Recruiting
Memphis, Tennessee, United States, 38103
Contact: James D Tutor, MD 901-287-5222 jtutor@utmem.edu
Contact: Barbara Culbreath, RN, BSN CCRC 901-287-5351 bculbreath@lebonheur.org
Principal Investigator: James D Tutor, MD
Sub-Investigator: Robert A Schoumacher, MD
Sub-Investigator: Saumini Srinivasin, MD
Sub-Investigator: Dennis C Stokes, MD
Sub-Investigator: Mike Christensen, Ph.D
Sub-Investigator: Barbara Culbreath, RN, BSN, CCRC

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:	Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine ( James D. Tutor, M.D. )
Study ID Numbers:	IRB#8819
Study First Received:	January 27, 2009
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00831038 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Tennessee:

pulmonary function tests
infants
chronic lung disease
dysphagia
chronic aspiration

Study placed in the following topic categories:

Deglutition Disorders
Respiratory Tract Diseases
Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on September 03, 2009