Adenoidectomy for Otitis Media in 2-3 Year Old Children

This study has been terminated.
Sponsor:
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:
NCT00016497
First received: May 10, 2001
Last updated: April 21, 2006
Last verified: April 2006
  Purpose

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.


Condition Intervention Phase
Otitis Media With Effusion
Procedure: bilateral myringotomy
Procedure: bilateral myringotomy and tubes
Procedure: adenoidectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Adenoidectomy for Otitis Media in 2-3 Year Old Children

Resource links provided by NLM:


Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Study Start Date: February 1997
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   24 Months to 47 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016497

Locations
United States, Pennsylvania
Ear, Nose, and Throat Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
Sponsors and Collaborators
Investigators
Principal Investigator: Margaretha L Casselbrant Children's Hospital of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00016497     History of Changes
Other Study ID Numbers: NIDCD1RO1DC035-04
Study First Received: May 10, 2001
Last Updated: April 21, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
otitis media with effusion
children
tympanostomy tubes
adenoidectomy

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014