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Trial record 12 of 994 for:
"Ear Diseases"
Genetics of Middle Ear Disease
This study has been completed.
Sponsor:
Children's Hospital of Pittsburgh
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Margaretha Casselbrant, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00422136
First received: January 12, 2007
Last updated: November 11, 2011
Last verified: November 2011
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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: | Observational Model: Family-Based Time Perspective: Cross-Sectional |
| Official Title: | Genetic Epidemiology of Otitis Media |
Resource links provided by NLM:
Further study details as provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:
Biospecimen Retention: Samples With DNA
Detailed Description:
Blood samples, DNA
| Enrollment: | 2121 |
| Study Start Date: | July 2002 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Using the twin study approach, the investigators 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. The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators 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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Families with 2 or more full sibs who had tympanostomy tubes inserted
Criteria
Inclusion Criteria:
- families: 2 or more full sibs who had tympanostomy tubes inserted
Exclusion Criteria:
- major congenital malformations
- medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations
- cared for in the Intensive Care Unit as neonate
- been on assisted ventilation
- known sensorineural hearing loss
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00422136
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422136
Locations
| United States, Pennsylvania | |
| ENT Research Center, Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
Sponsors and Collaborators
Children's Hospital of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
| Principal Investigator: | Margaretha L Casselbrant, MD, PhD | Children's Hospital of Pittsburgh |
More Information
Publications:
| Responsible Party: | Margaretha Casselbrant, Principal Investigator, Children's Hospital of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00422136 History of Changes |
| Other Study ID Numbers: |
R01DC005630 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 12, 2007 |
| Last Updated: | November 11, 2011 |
Keywords provided by Margaretha Casselbrant, Children's Hospital of Pittsburgh:
|
middle ear otitis genetics |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on August 18, 2017