Recurrent Acute Otitis MediaNCT05348291
Effect of Ventilation Tubes in Otitis-prone Children
A study testing ventilation tubes in people with Recurrent Acute Otitis Media, run by Lund University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Recurrent Acute Otitis Media
- What is being tested?
- ventilation tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 21 Oct 2022to May 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 2 years
- All sexes
- No healthy volunteers
- Child
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
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery
Lund, 22185
Tomas Andersson-Kronmark, MD, tomas.kronmark@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Acute Otitis Media
- Being tested
- ventilation tubes
- Keywords
- ventilation tubes, prevention, quality of life, antibiotic treatment, otitis media with effusion, audiometry, watchful waiting, tympanic membrane perforation
- Medical subject headings
- Otitis Media, Otitis Media with Effusion, Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation tubesDevice
Also called grommets
Transtympanic pressure equalising devices.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation tubes | Active comparator | Ventilation tube surgery Receives: Device: ventilation tubes |
| Active monitoring | No intervention | Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescriptions
Number of oral antibiotic prescriptions
Measured: First two years in study
Otitis media episodes
Number of otitis media episodes
Measured: First two years in study
Secondary outcomes (3)
Microbiology
Nasopharyngeal and middle ear growth during acute otitis media episodes
Measured: First two years in study
Tympanic membrane perforations
Presence of chronic tympanic membrane perforations
Measured: Until age 7
Audiometry
Audiometry, including high frequency audiometry
Measured: At age 4 and 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start21 Oct 2022
- Primary completionMay 2028 (estimated)
- Study completionMay 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348291
- Sponsor's protocol ID
- Rorstudien2022
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation Tubes for Recurrent Acute Otitis Media - Effects on Antibiotic Consumption and Otitis Media Episodes
- ClinicalTrials.gov ID
- NCT05348291
- Acronym / sponsor ID
- Rorstudien2022
- Conditions
- Recurrent Acute Otitis Media
- Keywords
- ventilation tubes, prevention, quality of life, antibiotic treatment, otitis media with effusion, audiometry, watchful waiting, tympanic membrane perforation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2033 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Ventilation tubes | Active comparator | Device: ventilation tubesVentilation tube surgery |
| Active monitoring | No intervention | –Active monitoring of patients, with the possibility to cross over to other arm if deemed necessary. |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilation tubesAlso: grommetsTranstympanic pressure equalising devices. | Device | Ventilation tubes |
Primary outcome
Antibiotic prescriptions
Time frame: First two years in study
Number of oral antibiotic prescriptions
Otitis media episodes
Time frame: First two years in study
Number of otitis media episodes
3 secondary outcomes
Microbiology
Time frame: First two years in study
Tympanic membrane perforations
Time frame: Until age 7
Audiometry
Time frame: At age 4 and 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Related trials for Recurrent Acute Otitis Media
Active, not recruiting
Posterior vs. Anterior Tympanostomy Tube Placement
Otitis Media in Children, Chronic Otitis Media With Effusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation tubes in people with Recurrent Acute Otitis Media, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Gisselsson-Solen, MD, PhD (+4646172815, marie.gisselsson-solen@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescriptions (time frame: First two years in study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023; AzTrials last refreshed its copy on 26 Oct 2026.