Status:
COMPLETED
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Otitis Media With Effusion
Eligibility:
All Genders
3-6 years
Brief Summary
This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their ...
Detailed Description
This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function ...
Eligibility Criteria
Inclusion
- 3-6 years old
- History of chronic otitis media with effusion(OME)
- Scheduled or within 6 weeks of tube insertion
- OME at entry or surgery
- Generally good health
Exclusion
- Cleft palate or other syndromes predisposing to OM
- History of recurrent acute otitis media only
- History of complications of OM or its treatment
- Unable to cooperate for testing
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00393900
Start Date
August 1 2006
End Date
October 1 2012
Last Update
October 19 2017
Active Locations (1)
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1
ENT Department, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213