Status:
UNKNOWN
Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
Lead Sponsor:
Instituto de Ciências Biomédicas Abel Salazar
Conditions:
Otitis Media With Effusion
Hearing Loss
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
Otitis media with effusion (OME) is a common finding affecting children and the main cause of acquired hearing loss in the pediatric age. OBJECTIVES The purpose of the clinical study is to determine...
Detailed Description
1. Introduction Otitis media with effusion (OME) is a common finding affecting children in the age of 2-6 years. Although OME is the main cause of acquired hearing loss in the pediatric age, it's ...
Eligibility Criteria
Inclusion
- \- Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist.
- \- Exclusion criteria: Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery.
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05324696
Start Date
November 1 2020
End Date
December 3 2023
Last Update
August 24 2022
Active Locations (1)
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1
Centro Hospitalar Univrsitário do Porto
Porto, Portugal, 4099-001