Status:
RECRUITING
Effect of Ventilation Tubes in Otitis-prone Children
Lead Sponsor:
Lund University
Conditions:
Recurrent Acute Otitis Media
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effects of ventilation tubes in children with recurrent ear infections. By drawing lots, young children with recurrent ear infections will be assigned t...
Detailed Description
Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the natu...
Eligibility Criteria
Inclusion
- At inclusion, children should be under 1 year of age and fulfil the internationally accepted definition of recurrent AOM, ie have had 3 episodes of AOM during the last 6 months, or 4 during the last 12 months.
- \-
Exclusion
- chromosomal aberrations, cleft palate or severe immune deficiency
- \-
Key Trial Info
Start Date :
October 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2033
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05348291
Start Date
October 21 2022
End Date
May 1 2033
Last Update
March 20 2023
Active Locations (1)
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1
Department of Otorhinolaryngology, Head and Neck Surgery
Lund, Sweden, 22185