Genetics of Middle Ear Disease

This study has been completed.
Sponsor:
Collaborator:
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

January 12, 2007
November 11, 2011
July 2002
July 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00422136 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetics of Middle Ear Disease
Genetic Epidemiology of Otitis Media

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.

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.

Observational
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood samples, DNA

Non-Probability Sample

Families with 2 or more full sibs who had tympanostomy tubes inserted

Otitis Media
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2121
July 2009
July 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422136
R01 DC05630, R01DC005630
No
Margaretha Casselbrant, Children's Hospital of Pittsburgh
Children's Hospital of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Margaretha L Casselbrant, MD, PhD Children's Hospital of Pittsburgh
Children's Hospital of Pittsburgh
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP