Research
Recurrence of Ear Disease After Tubes Study
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Protocol Description
This study will determine if it is possible to use certain tests, such as Eustachian tube function tests and gas exchange tests, to predict whether or not a child who had tubes surgically placed in their eardrum because of otitis media will redevelop the disease again after the tubes stop working. The results will be used to support or refute tested components of existing models of middle-ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after a tympanostomy tube extrudes or is no longer functioning.
Eligibility Criteria
Children of both genders, ages 3 to 6 years, with a history of chronic otitis media with effusion (middle ear fluid) who are scheduled for, or are within 6 weeks of, tube insertion may be eligible for this program
Boys: 3 to 6 years old
Girls: 3 to 6 years old
Requirements
Researchers will measure middle-ear gas demand, middle-ear volume and Eustachian tube function between the time of tube insertion and extrusion or nonfunctioning. Tests will be done at 2 and 6 weeks after tubes are inserted, and at 3, 5, 8 and 12 months, and thereafter every 3 months, until the tubes are no longer working. At that point, each participant will receive monthly examinations for up to 12 months.
Visits: No fewer than 6
Duration: Up to 12 months after the tubes have stopped working
Status: Open for Enrollment
Source of Support
National Institutes of Health
Additional Resources
Study description at National Institutes of Health
Primary Investigator(s)
Ellen M. Mandel, MD
Contact Information
To get started, please contact:
Kathy Tekely, RN or Jim Seroky, MA
412-692-5463
