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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
  Purpose

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
Otitis Media

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Epidemiology of Otitis Media

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Blood samples, DNA


Enrollment: 2121
Study Start Date: July 2002
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422136

Locations
United States, Pennsylvania
ENT Research Center, Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Margaretha L Casselbrant, MD, PhD Children's Hospital of Pittsburgh
  More Information

Publications:
Responsible Party: Margaretha Casselbrant, Principal Investigator, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00422136     History of Changes
Other Study ID Numbers: R01 DC05630, R01DC005630
Study First Received: January 12, 2007
Last Updated: November 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
middle ear
otitis
genetics

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 19, 2014