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临床试验/NCT00423072
NCT00423072已完成不适用

Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2006年8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
82
试验地点
1
主要终点
otitis media

研究概览

简要总结

The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.

详细描述

Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • birth-24 months
  • unrepaired or recently repaired cleft palate

排除标准

  • cleft palate associated with syndrome
  • known immune deficiency

结局指标

主要结局

otitis media

时间窗: 5 years

status of middle ear at 5 years of age

次要结局

  • anatomic variables(3 and 5 years)
  • Eustachian tube function testing(pre- and post palatoplasty, yearly to age 18 yrs)

研究者

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

Cuneyt M. Alper

Professor, Otolaryngology

University of Pittsburgh

研究点 (1)

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