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| Sponsors and Collaborators: |
Children's Hospital of Pittsburgh National Institute on Deafness and Other Communication Disorders (NIDCD) |
|---|---|
| Information provided by: | Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00422136 |
Purpose
The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.
| Condition |
|---|
|
Otitis Media |
| Study Type: | Observational |
| Study Design: | Family-Based, Cross-Sectional |
| Official Title: | Genetic Epidemiology of Otitis Media |
Blood samples, DNA
| Estimated Enrollment: | 2000 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Using the twin study approach, we demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component. The point estimate of heritability of time with MEE was 0.73. While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown. Our overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow us to balance cost efficiency with statistical power. Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. A blood sample will be obtained from each subject for genotyping.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Families with 2 or more full sibs who had tympanostomy tubes inserted
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| ENT Research Center, Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Margaretha L Casselbrant, MD, PhD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh School of Medicine ( Margaretha L. Casselbrant, MD, PhD ) |
| Study ID Numbers: | R01 DC05630 |
| Study First Received: | January 12, 2007 |
| Last Updated: | February 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00422136 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
middle ear otitis genetics |
|
Otorhinolaryngologic Diseases Otitis Otitis Media Ear Diseases |
|
Otorhinolaryngologic Diseases Otitis Otitis Media Ear Diseases |
