Clinical trial NCT00162994: Prevention Recurrent Otitis Media in the Young Children
Official title: Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otitis Media
Keywords: recurrent otitis media
adenoidectomy
tympanostomy
young children
prevention
quality of life
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* at least 3 otitis media episodes during the last half year
* address near (\< 50 km) the university hospital of Oulu

Exclusion Criteria:

* 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

Primary outcomes:
measure: - number of acute otitis media
measure: - quality of life issues
Secondary outcomes:
measure: - time to first recurrence
measure: - speed of recovery of each otitis media
measure: - number of days of middle ear effusion
measure: - number of upper respiratory infections
measure: - prevention of otitis media caused by pnemococcus in carrier of pneumococcus
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Petri Koivunen, PhD
role: STUDY_DIRECTOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Olli-Pekka Alho, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Pediatrics, University of Oulu, Finland
name: Matti Uhari, professor
role: STUDY_DIRECTOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Tiia Kujala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Jukka Luotonen, PhD
role: STUDY_DIRECTOR
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Aila Kristo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of pediatrics, University of Oulu, Finland
name: Marjo Renko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of pediatrics, University of Oulu, Finland
name: Tero Kontiokari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of pediatrics, University of Oulu, Finland
name: Tytti Pokka, FK
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kujala 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.