A Pilot Study of Pulmonary Function in Dysphagic Infants

Chronic Lung Disease Clinical Trial

Official title:

A Pilot Study of Pulmonary Function in Dysphagic Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831038
• Other study ID #: IRB#8819
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: November 28, 2011
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 24 Months

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
United States	LeBonheur Children's Medical Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant pulmonary function test results		On admission to study and 6 months later	No