Effect of Ventilation Tubes in Otitis-prone Children

Recurrent Acute Otitis Media Clinical Trial

Official title:

Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348291
• Other study ID #: Rorstudien2022
• Status: Recruiting
• Phase: N/A
• 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
• 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 child´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.

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Exclusion Criteria: chromosomal aberrations, cleft palate or severe immune deficiency

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Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Recurrent Acute Otitis Media

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