Adenoidectomy for Otitis Media in 2-3 Year Old Children

April 21, 2006 updated by: National Institute on Deafness and Other Communication Disorders (NIDCD)
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The specific aim of this study is to compare, by means of a randomized clinical trial, the efficacy of three surgical treatment combinations: adenoidectomy with myringotomy (A-M), adenoidectomy with myringotomy and tympanostomy tube insertion (A-M&T), and M&T alone, in reducing subsequent middle ear disease in children aged 24-47 months with otitis media with effusion (OME) of at least 3 months' duration unresponsive to standardized, recent antimicrobial treatment. The children are randomly assigned to one of three treatment arms: 1. M&T; 2. A-M; and 3. A-M&T. Subjects are be stratified according to: 1. age; 2. nasal obstruction; and 3. previous tubes. All subjects are scheduled for surgery according to assignment within 4 weeks after entry. The first post-operative visit takes place 2 weeks after surgery, and a complete examination of the ears, nose, and throat (ENT exam) including pneumatic otoscopy, tympanometry and audiometry is performed. Subjects are followed with monthly evaluations (ENT-exam, pneumatic otoscopy, tympanometry) for three years. Audiometry is performed every 6 months. All subjects are evaluated at any time while still enrolled in the study if signs and symptoms of URI, acute otitis media (AOM, including otorrhea), or OME occur and are treated appropriately. Subjects who develop OME for 4 months bilaterally or 6 months unilaterally have M&T and continue to be followed in the study. The primary outcome measure will be percentage of time with middle ear effusion (MEE). Episodes of AOM, otorrhea, and OME, time to first recurrence, and number of surgical procedures will be compared between the three treatment groups. Treatment failures, complications and sequelae of treatments will also be recorded and compared among the three treatment groups.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2583
        • Ear, Nose, and Throat Research Center, Children's Hospital of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Males and females between 24 and 47 months of age, in good general health.
  • Asymptomatic otitis media with effusion bilaterally for a minimum of 3 consecutive months.
  • At least one 10-day course of a broad-spectrum antimicrobial agent in the last month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Margaretha L Casselbrant, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

May 10, 2001

First Submitted That Met QC Criteria

May 11, 2001

First Posted (ESTIMATE)

May 14, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2006

Last Update Submitted That Met QC Criteria

April 21, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCD1RO1DC035-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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