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临床试验/NCT03708406
NCT03708406已完成不适用

Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Audiometry

研究概览

简要总结

OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.

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
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Audiometry

时间窗: 1 day

evaluation of the hearing threshold

次要结局

  • nasal ventilation(1 day)
  • Eustachian tube function(1 day)
  • Facial 3D scan(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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