A Pilot Study of Pulmonary Function in Dysphagic Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lung Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pulmonary function tests infants chronic lung disease dysphagia chronic aspiration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infant Pulmonary Function Tests

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James D. Tutor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James D Tutor, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LeBonheur Children's Medical Center

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB#8819

Identifier Type: -

Identifier Source: org_study_id