Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion |
Buccal cells obtained for DNA
| Enrollment: | 84 |
| Study Start Date: | August 2006 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Children with tympanostomy tubes for chronic OME
|
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 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:
- 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 Criteria:
- 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
Contacts and Locations| United States, Pennsylvania | |
| ENT Department, Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| 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
No publications provided
| Responsible Party: | William J Doyle, PhD, Professor of Otolaryngology, Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00393900 History of Changes |
| Other Study ID Numbers: | #0605013, NIH 1P50DC007667 |
| Study First Received: | October 30, 2006 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital of Pittsburgh:
|
otitis media tympanostomy tube eustachian tube function gas exchange tympanostomy tubes |
Additional relevant MeSH terms:
|
Otitis Otitis Media Otitis Media with Effusion Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013