NCT00502450

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2007

First QC Date

July 15, 2007

Last Update Submit

July 18, 2013

Conditions

Acute MastoiditisAcute Otitis Media

Keywords

Acute mastoiditisHearing lossMastoidectomyAudiogram

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Tertiary care clinic

You may qualify if:

  • History of acute mastoiditis 4 years and older

You may not qualify if:

  • Younger than 4 years old Not cooperative for hearing test Active ear disease Major medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children'S Hospital

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Otitis MediaHearing Loss

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eyal Raveh, MD

    Rabin Medical Center

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2007

First Posted

July 17, 2007

Study Start

September 1, 2007

Last Updated

July 19, 2013

Record last verified: 2007-07

Locations

IL(1)