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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00547326
Other study ID # 2007/397
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information

Verified date July 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria: - children between 3 and 7 years old - Bilateral otitis media with effusion - Tympanogram type B Exclusion Criteria: - ventilation tubes - Damage of the tympanic membrane - Operation of the tympanic membrane - Other illness e.g. Down, craniofacial abnormalities,…

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
treated with osteopatic cranial techniques
treated with osteopatic cranial techniques
Treatment with placebo
Treatment with placebo

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Audiometric and tympanometric results directly after every session of treatment (3 times, once a week)
Secondary Audiometric and tympanometric results one week after the last treatment session.
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