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Genetics of Middle Ear Disease
This study is ongoing, but not recruiting participants.
Study NCT00422136   Information provided by Children's Hospital of Pittsburgh
First Received: January 12, 2007   Last Updated: February 13, 2009   History of Changes

January 12, 2007
February 13, 2009
July 2002
July 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00422136 on ClinicalTrials.gov Archive Site
 
 
 
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, we 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. Our overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow us 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
Family-Based, Cross-Sectional
Otitis Media
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2000
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
 
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422136
Margaretha L. Casselbrant, MD, PhD, University of Pittsburgh School of Medicine
R01 DC05630
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
February 2009

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