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Clinical Trials/NCT00422136
NCT00422136
Completed
Not Applicable

Genetic Epidemiology of Otitis Media

University of Pittsburgh1 site in 1 country2,121 target enrollmentJuly 2002
ConditionsOtitis Media

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otitis Media
Sponsor
University of Pittsburgh
Enrollment
2121
Locations
1
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2002
End Date
July 2009
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaretha L. Casselbrant

Principal Investigator

University of Pittsburgh

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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