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ClinicalTrials.gov Identifier: NCT00422136
Recruitment Status :
First Posted : January 15, 2007
Last Update Posted : November 14, 2017
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Margaretha L. Casselbrant, University of Pittsburgh
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 or disease
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.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Families with 2 or more full sibs who had tympanostomy tubes inserted
families: 2 or more full sibs who had tympanostomy tubes inserted
major congenital malformations
medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations