Otitis MediaNCT00162994
Prevention Recurrent Otitis Media in the Young Children
A study testing adenoidectomy and tymapanostomy in people with Otitis Media, run by Oulu University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media. Read more about this study
- Who is it for?
- Ages 10 to 24 months
- Conditions the study is for
- Otitis Media
- What is being tested?
- adenoidectomy and tymapanostomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2002to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at least 3 otitis media episodes during the last half year
- address near (< 50 km) the university hospital of Oulu
Who cannot join
- otitis media effusion lasting longer than two months without acute exacerbations
- prior adenoidectomy or tympanostomy
- head or neck malformation
- retarded child
- serious disease
- chemoprophylaxis for another disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
The purpose of this study is to find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.
Read the detailed description
Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.
In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.
- Conditions
- Otitis Media
- Being tested
- adenoidectomy and tymapanostomy
- Keywords
- recurrent otitis media, adenoidectomy, tympanostomy, young children, prevention, quality of life
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenoidectomy and tymapanostomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
- number of acute otitis media
- quality of life issues
Secondary outcomes (5)
- time to first recurrence
- speed of recovery of each otitis media
- number of days of middle ear effusion
- number of upper respiratory infections
- prevention of otitis media caused by pnemococcus in carrier of pneumococcus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startFeb 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Petri Koivunen, PhD, Study director, Dept of Otolaryngology, University of Oulu, FinlandOlli-Pekka Alho, professor, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandMatti Uhari, professor, Study director, Dept of Pediatrics, University of Oulu, FinlandTiia Kujala, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandJukka Luotonen, PhD, Study director, Dept of Otolaryngology, University of Oulu, FinlandAila Kristo, MD, Principal investigator, Dept of Otolaryngology, University of Oulu, FinlandMarjo Renko, PhD, Principal investigator, Dept of pediatrics, University of Oulu, FinlandTero Kontiokari, PhD, Principal investigator, Dept of pediatrics, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162994
- Sponsor's protocol ID
- K53715
- Status last verified
- Feb 2002
- First submitted
- 10 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Publications
Kujala T, Alho OP, Kristo A, Uhari M, Renko M, Pokka T, Koivunen P. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014 Jul;33(7):715-9. doi: 10.1097/INF.0000000000000265.
PubMed 24445832Kujala T, Alho OP, Luotonen J, Kristo A, Uhari M, Renko M, Kontiokari T, Pokka T, Koivunen P. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J. 2012 Jun;31(6):565-9. doi: 10.1097/INF.0b013e318255ddde.
PubMed 22466327
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
- ClinicalTrials.gov ID
- NCT00162994
- Acronym / sponsor ID
- K53715
- Conditions
- Otitis Media
- Keywords
- recurrent otitis media, adenoidectomy, tympanostomy, young children, prevention, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Aug 2005
- First posted
- 13 Sep 2005 (estimated)
- 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 find out if young children have more benefit of the combination of adenotomy and tympanostomy than plain tympanostomy in prevention of recurrent otitis media.
Detailed description
Recurrent otitis media is the most common bacterial disease in young children. Many risk factors are known, but benefit of operations are conflicting in children under two years of age.
In this randomized prospective controlled trial, the effect of tympanostomy tubes is compared to the effect of the combination of adenotomy and tympanostomy tubes in preventing recurrent otitis media. A control group with no active treatment is also included. The speed of recovery is studied by recording the daily symptoms and number of days of effusion comparing the differences between the groups. Life quality issues are recorded preoperatively and at about four and twelve months after the operation and are compared between the groups and to healthy children of the same age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- at least 3 otitis media episodes during the last half year
- address near (< 50 km) the university hospital of Oulu
Key exclusion criteria (6 listed)
- otitis media effusion lasting longer than two months without acute exacerbations
- prior adenoidectomy or tympanostomy
- head or neck malformation
- retarded child
- serious disease
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 |
|---|---|---|
| adenoidectomy and tymapanostomy | Procedure or surgery | – |
Primary outcome
- number of acute otitis media
- quality of life issues
5 secondary outcomes
- time to first recurrence
- speed of recovery of each otitis media
- number of days of middle ear effusion
- number of upper respiratory infections
- prevention of otitis media caused by pnemococcus in carrier of pneumococcus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
- Derived from this study: PubMed 24445832Kujala T, Alho OP, Kristo A, Uhari M, Renko M, Pokka T, Koivunen P. Quality of life after surgery for recurrent otitis media in a randomized controlled trial. Pediatr Infect Dis J. 2014 Jul;33(7):715-9. doi: 10.1097/INF.0000000000000265.
- Derived from this study: PubMed 22466327Kujala T, Alho OP, Luotonen J, Kristo A, Uhari M, Renko M, Kontiokari T, Pokka T, Koivunen P. Tympanostomy with and without adenoidectomy for the prevention of recurrences of acute otitis media: a randomized controlled trial. Pediatr Infect Dis J. 2012 Jun;31(6):565-9. doi: 10.1097/INF.0b013e318255ddde.
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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. This study is not recruiting at the moment.
Petri Koivunen, PhD study director
Dept of Otolaryngology, University of Oulu, Finland
Olli-Pekka Alho, professor principal investigator
Dept of Otolaryngology, University of Oulu, Finland
Matti Uhari, professor study director
Dept of Pediatrics, University of Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adenoidectomy and tymapanostomy in people with Otitis Media, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 21 Dec 2005. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- number of acute otitis media. 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?
On the ClinicalTrials.gov record for NCT00162994, which also lists 2 linked publications.
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 21 Dec 2005.