Prevention Recurrent Otitis Media in the Young Children

Effect of Adenotomy and Tympanostomy on Preventing Recurrent Otitis Media in the Young Children

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162994

Enrollment

300

Registered

2005-09-13

Start date

2002-02-28

Completion date

2005-08-31

Last updated

2005-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

recurrent otitis media, adenoidectomy, tympanostomy, young children, prevention, quality of life

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.

Interventions

PROCEDUREadenoidectomy and tymapanostomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

10 Months to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- number of acute otitis media	—
- quality of life issues	—

Secondary

Measure	Time frame
- number of days of middle ear effusion	—
- time to first recurrence	—
- prevention of otitis media caused by pnemococcus in carrier of pneumococcus	—
- number of upper respiratory infections	—
- speed of recovery of each otitis media	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026