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| Sponsor: | Children's Hospital of Pittsburgh |
|---|---|
| Collaborator: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by: | Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00393900 |
Purpose
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 eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.
| Condition |
|---|
|
Otitis Media With Effusion |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion |
Buccal cells obtained for DNA
| Estimated Enrollment: | 140 |
| Study Start Date: | August 2006 |
| Groups/Cohorts |
|---|
|
1
Children with tympanostomy tubes for chronic OME
|
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 longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies 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 tympanostomy tube extrusion/nonfunctioning.
Eligibility| Ages Eligible for Study: | 3 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media with effusion within the 6 weeks prior to study enrollment
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ellen M Mandel, MD | 412-692-5463 | |
| Contact: Kathy Tekely, RN | 412-692-5463 |
| United States, Pennsylvania | |
| ENT Department, Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Kathy Tekely, RN 412-692-5463 | |
| Sub-Investigator: Ellen M Mandel, MD | |
| Principal Investigator: | William J Doyle, PhD | Department of Otolaryngology, Children's Hospital of Pittsburgh |
| Study Director: | Ellen Mandel, MD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh School of Medicine ( William J. Doyle, PhD ) |
| Study ID Numbers: | #0605013, NIH 1P50DC007667 |
| Study First Received: | October 30, 2006 |
| Last Updated: | December 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00393900 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
otitis media tympanostomy tube eustachian tube function gas exchange tympanostomy tubes |
|
Otorhinolaryngologic Diseases Otitis Media Otitis Ear Diseases Otitis Media with Effusion |
