NCT00162994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

December 21, 2005

Status Verified

February 1, 2002

First QC Date

September 10, 2005

Last Update Submit

December 20, 2005

Conditions

Otitis Media

Keywords

recurrent otitis mediaadenoidectomytympanostomyyoung childrenpreventionquality of life

Outcome Measures

Primary Outcomes (2)

  • - 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

Interventions

adenoidectomy and tymapanostomyPROCEDURE

Eligibility Criteria

Age10 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Publications (2)

  • 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.

    PMID: 24445832DERIVED

  • 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.

    PMID: 22466327DERIVED

MeSH Terms

Conditions

Otitis Media

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Petri Koivunen, PhD

    Dept of Otolaryngology, University of Oulu, Finland

    STUDY DIRECTOR

  • Olli-Pekka Alho, professor

    Dept of Otolaryngology, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Matti Uhari, professor

    Dept of Pediatrics, University of Oulu, Finland

    STUDY DIRECTOR

  • Tiia Kujala, MD

    Dept of Otolaryngology, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Jukka Luotonen, PhD

    Dept of Otolaryngology, University of Oulu, Finland

    STUDY DIRECTOR

  • Aila Kristo, MD

    Dept of Otolaryngology, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Marjo Renko, PhD

    Dept of pediatrics, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Tero Kontiokari, PhD

    Dept of pediatrics, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Tytti Pokka, FK

    Dept of pediatrics, University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 13, 2005

Study Start

February 1, 2002

Study Completion

August 1, 2005

Last Updated

December 21, 2005

Record last verified: 2002-02

Locations

FI(1)