Acute Otitis Media Clinical Trial
| NCT number | NCT00502450 |
| Other study ID # | 4560 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | July 15, 2007 |
| Last updated | July 18, 2013 |
| Start date | September 2007 |
| Verified date | July 2007 |
| Source | Rabin Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - History of acute mastoiditis 4 years and older Exclusion Criteria: - Younger than 4 years old Not cooperative for hearing test Active ear disease Major medical illness |
Observational Model: Case Control, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Israel | Schneider Children'S Hospital | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
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