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A Pilot Study of Pulmonary Function in Dysphagic Infants

University of Tennessee logo

University of Tennessee

Status

Completed

Conditions

Chronic Lung Disease

Treatments

Procedure: Infant Pulmonary Function Tests

Study type

Interventional

Funder types

Other

Identifiers

NCT00831038
IRB#8819

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

1 to 24 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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