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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422136
Other study ID # R01DC005630
Secondary ID R01DC005630
Status Completed
Phase N/A
First received January 12, 2007
Last updated November 10, 2017
Start date July 2002
Est. completion date July 2009

Study information

Verified date November 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2121
Est. completion date July 2009
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States ENT Research Center, Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Casselbrant ML, Mandel EM, Jung J, Ferrell RE, Tekely K, Szatkiewicz JP, Ray A, Weeks DE. Otitis media: a genome-wide linkage scan with evidence of susceptibility loci within the 17q12 and 10q22.3 regions. BMC Med Genet. 2009 Sep 3;10:85. doi: 10.1186/147 — View Citation

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