MedTrace Logo

Adenoidectomy for Otitis Media in 2-3 Year Old Children

NCT00016497 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-04-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of three different surgical treatments (1. Bilateral myringotomy and tube insertion (M\&T); 2. Adenoidectomy and bilateral myringotomy (A\&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T)) in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in the middle ear in children aged 24-47 months. The fluid in the middle ear is of at least three months' duration and unresponsive to standardized, recent antimicrobial treatment. The children are assigned to one of the three surgical treatments. After surgery, they are followed with examinations monthly and at the time of intercurrent infections for three years.

Conditions

  • Otitis Media With Effusion

Interventions

PROCEDURE

bilateral myringotomy

PROCEDURE

bilateral myringotomy and tubes

PROCEDURE

adenoidectomy

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    lead NIH

Principal Investigators

  • Margaretha L Casselbrant · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-02-28
Completion
2007-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00016497 on ClinicalTrials.gov