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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05348291
Other study ID # Rorstudien2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2022
Est. completion date May 2033

Study information

Verified date March 2023
Source Lund University
Contact Marie Gisselsson-Solen, MD, PhD
Phone +4646172815
Email marie.gisselsson-solen@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Children who fulfil the criteria of recurrent acute otitis media (AOM) before they are one year of age will be randomised to ventilation tube surgery or active monitoring (50% vs 50%). Due to the nature of the intervention, blinding will not be possible. Children randomised to are randomised to active monitoring and continue to have frequent recurrences will be given the opportunity to cross between groups. Children will be followed by the study doctors every third month until the age of two years, and after this yearly. In addition to planned visits, the families will be advised to contact the study doctors whenever they suspect that their child has a new episode of AOM. Otomicroscopy and nasopharyngeal cultures will be performed at every visit; cultures from the external ear canal will be taken when applicable. It will also be noted whether there is any perforation of the tympanic membrane, whether ventilation tubes are still in place, whether there is an ongoing episode of AOM or of otitis media with effusion (OME). At each planned visit, a parental quality of life questionnaire for children with ear disease will be completed. It will be noted how many AOM episodes the child has had since the last planned visit, how many times the patient has been prescribed oral antibiotics (also for reasons other than AOM), and if the family has seen a doctor elsewhere. At each emergency visit, it will be noted if the child has AOM or not, whether the child has fever, any signs of complications to AOM, a spontaneous perforation and whether the childĀ“s general well-being is affected. At the ages of 4 and 7 years and, if a hearing impairment is suspected on any other occasion, hearing tests will be performed.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 2033
Est. primary completion date May 2028
Accepts healthy volunteers No
Gender All
Age group 1 Year to 2 Years
Eligibility 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ventilation tubes
Transtympanic pressure equalising devices.

Locations

Country Name City State
Sweden Department of Otorhinolaryngology, Head and Neck Surgery Lund

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibiotic prescriptions Number of oral antibiotic prescriptions First two years in study
Primary Otitis media episodes Number of otitis media episodes First two years in study
Secondary Microbiology Nasopharyngeal and middle ear growth during acute otitis media episodes First two years in study
Secondary Tympanic membrane perforations Presence of chronic tympanic membrane perforations Until age 7
Secondary Audiometry Audiometry, including high frequency audiometry At age 4 and 7 years
See also
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Recruiting NCT06191562 - Posterior vs. Anterior Tympanostomy Tube Placement N/A
Completed NCT00941993 - Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus N/A