A Pilot Study of Pulmonary Function in Dysphagic Infants

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.

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Key information

Conditions

Chronic Lung Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LeBonheur Children's Medical Center

Memphis, Tennessee, 38103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant Pulmonary Function Tests

Procedure

Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.

Primary outcomes

infant pulmonary function test results

Time frame: On admission to study and 6 months later

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jan 28, 2009
Registry last updated: Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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