Effect of Ventilation Tubes in Otitis-prone Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Acute Otitis Media
• Intervention / Treatment: Device: ventilation tubes

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Gisselsson-Solen, MD, PhD; Phone Number: +4646172815; Email: marie.gisselsson-solen@med.lu.se
• Study Contact Backup: Name: Ann Hermansson, Professor; Phone Number: +4646171360; Email: ann.hermansson@med.lu.se

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Recruiting
    • Department of Otorhinolaryngology, Head and Neck Surgery
    • Contact: Tomas Andersson-Kronmark, MD; Email: tomas.kronmark@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ventilation tubes; Ventilation tube surgery	Device: ventilation tubes; Transtympanic pressure equalising devices.; Other Names: grommets
No Intervention: Active monitoring; Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic prescriptions	Number of oral antibiotic prescriptions	First two years in study
Otitis media episodes	Number of otitis media episodes	First two years in study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiology	Nasopharyngeal and middle ear growth during acute otitis media episodes	First two years in study
Tympanic membrane perforations	Presence of chronic tympanic membrane perforations	Until age 7
Audiometry	Audiometry, including high frequency audiometry	At age 4 and 7 years

Collaborators and Investigators

• Sponsor: Lund University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Anticipated): May 1, 2028
• Study Completion (Anticipated): May 1, 2033

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; prevention; ventilation tubes; antibiotic treatment; otitis media with effusion; audiometry; watchful waiting; tympanic membrane perforation
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: Rorstudien2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No