NCT00016497

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Feb 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2001

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2001

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

May 10, 2001

Last Update Submit

April 21, 2006

Conditions

Otitis Media With Effusion

Keywords

otitis media with effusionchildrentympanostomy tubesadenoidectomy

Interventions

bilateral myringotomyPROCEDURE
bilateral myringotomy and tubesPROCEDURE
adenoidectomyPROCEDURE

Eligibility Criteria

Age24 Months - 47 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ear, Nose, and Throat Research Center, Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2583, United States

Location

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Margaretha L Casselbrant

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2001

First Posted

May 14, 2001

Study Start

February 1, 1997

Study Completion

January 1, 2007

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations

US(1)