Chronic Lung DiseaseNCT00831038
A Pilot Study of Pulmonary Function in Dysphagic Infants
A study testing Infant Pulmonary Function Tests in people with Chronic Lung Disease, run by University of Tennessee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- Infant Pulmonary Function Tests
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants between ages 1-24 months who have been newly diagnosed with dysphagia
Who cannot join
- cystic fibrosis
- obstructive sleep apnea
- seizures
- allergy or adverse reaction to chloral hydrate
- heart disease
- liver disease
Show all 16Show fewer
- kidney disease
- pneumonia
- pleural effusion
- neuromuscular disease
- major congenital anomalies
- tracheoesophageal fistula
- vascular ring
- bronchopulmonary dysplasia
- pharyngeal anomalies
- Arnold-Chiari malformation
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103
About this study
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.
Read the 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.
- Conditions
- Chronic Lung Disease
- Being tested
- Infant Pulmonary Function Tests
- Keywords
- pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Pulmonary Function TestsProcedure or surgery
Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.
What is being measured
The primary outcome is the main question the study is designed to answer.
infant pulmonary function test results
Measured: On admission to study and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James D. Tutor, M.D., University of Tennessee
- Investigators
- James D Tutor, MD, Principal investigator, Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831038
- Sponsor's protocol ID
- IRB#8819
- Status last verified
- Nov 2011
- First submitted
- 27 Jan 2009
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pulmonary Function in Dysphagic Infants
- ClinicalTrials.gov ID
- NCT00831038
- Acronym / sponsor ID
- IRB#8819
- Conditions
- Chronic Lung Disease
- Keywords
- pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants between ages 1-24 months who have been newly diagnosed with dysphagia
Key exclusion criteria (16 listed)
- cystic fibrosis
- obstructive sleep apnea
- seizures
- allergy or adverse reaction to chloral hydrate
- heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Pulmonary Function TestsTests will be performed on study patients within 1 week of study enrollment and again 6 months later. | Procedure or surgery | – |
Primary outcome
infant pulmonary function test results
Time frame: On admission to study and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Tutor, MD principal investigator
Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Pulmonary Function Tests in people with Chronic Lung Disease, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infant pulmonary function test results (time frame: On admission to study and 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.