RecruitingNot Applicable

Effect of Ventilation Tubes in Otitis-prone Children

Sweden150 participantsStarted 2022-10-21

Plain-language 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.

Who can participate

Age range1 Year – 2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: chromosomal aberrations, cleft palate or severe immune deficiency \-

What they're measuring

Antibiotic prescriptions

Timeframe: First two years in study

Otitis media episodes

Timeframe: First two years in study

Trial details

NCT IDNCT05348291

SponsorLund University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Marie Gisselsson-Solen, MD, PhD

+4646172815 marie.gisselsson-solen@med.lu.se

View on ClinicalTrials.gov More Recurrent Acute Otitis Media trials