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临床试验/NCT00422136
NCT00422136已完成不适用

Genetic Epidemiology of Otitis Media

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 2,121 人开始时间: 2002年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,121
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • families: 2 or more full sibs who had tympanostomy tubes inserted

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaretha L. Casselbrant

Principal Investigator

University of Pittsburgh

研究点 (1)

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