Investigating the effects of ventilation tubes in children with recurrent ear infections
Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Year to 2 Years |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT05348291 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under one year of age who have experienced recurrent acute otitis media.
Not a fit: Patients with chromosomal aberrations, cleft palate, or severe immune deficiency may not benefit from this study.
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 performed: Previous studies have shown varying success with similar interventions, but this specific approach is being evaluated for the first time in this context.
Eligibility criteria
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 this trial is running
Lund
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.