Investigating the effects of ventilation tubes in children with recurrent ear infections
Official title: Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
Run by Lund University · NCT05348291 · Data updated 2026-11-12
This study is testing if putting ventilation tubes in the ears of babies under one year old can help prevent them from getting repeated ear infections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 2 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Lund) |
| Status | Recruiting |
| Started | October 21, 2022 |
| Main results expected | May 2028 |
| Study ends | May 2033 |
| Registry record updated | March 20, 2023 |
| Trial ID | NCT05348291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under one year of age who have experienced recurrent acute otitis media.
✕Probably not a fit
Patients with chromosomal aberrations, cleft palate, or severe immune deficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of ventilation tubes in preventing recurrent acute otitis media (AOM) in children under one year of age. Participants will be randomly assigned to receive either ventilation tube surgery or active monitoring, with follow-ups every three months until age two and annually thereafter. The study will track the frequency of ear infections and antibiotic prescriptions, as well as assess the quality of life for the children involved. The study will also allow for crossover between groups if children in the monitoring group continue to experience frequent infections.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of recurrent ear infections in young children, improving their quality of life.
How similar studies have gone: Previous studies have shown varying success with similar interventions, but this specific approach is being evaluated for the first time in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \-
Where it's running
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Department of Otorhinolaryngology, Head and Neck Surgery
Lund, Sweden Recruiting
Study contacts
- Study coordinator: Marie Gisselsson-Solen, MD, PhD
- Email: marie.gisselsson-solen@med.lu.se
- Phone: +4646172815
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.