Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 to one of two groups (ventilation tubes or close follow-up), and the number of ear infections and antibiotic prescriptions in each group will be monitored. The study participants will be followed until they are 7 years old.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 2
Healthy Volunteers: f
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Locations
Other Locations
Sweden
Department of Otorhinolaryngology, Head and Neck Surgery
RECRUITING
Lund
Contact Information
Primary
Marie Gisselsson-Solen, MD, PhD
marie.gisselsson-solen@med.lu.se
+4646172815
Backup
Ann Hermansson, Professor
ann.hermansson@med.lu.se
+4646171360
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2033-05
Participants
Target number of participants: 150
Treatments
Active_comparator: Ventilation tubes
Ventilation tube surgery
No_intervention: Active monitoring
Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.
Related Therapeutic Areas
Sponsors
Leads: Lund University