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Clinical Trials in Sweden / NCT05348291
Recruiting Not applicable

Effect of Ventilation Tubes in Otitis-prone Children

NCT05348291 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lund University
Phase
Not applicable
Started
2022-10-21
Last updated
2023-03-20

Condition(s) studied

Recurrent Acute Otitis Media

Investigational drug(s) / intervention(s)

ventilation tubes

ventilation tubes: Transtympanic pressure equalising devices.

Study 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

Sex
ALL
Min age
1 Year
Max age
2 Years
Healthy volunteers
No
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 \-

Primary outcome measure(s)

  • Antibiotic prescriptions — First two years in study
    Number of oral antibiotic prescriptions
  • Otitis media episodes — First two years in study
    Number of otitis media episodes

Trial sites (1)

FacilityCityRegionStatus
Department of Otorhinolaryngology, Head and Neck Surgery Lund Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05348291 on ClinicalTrials.gov ↗ ← All trials in Sweden