Adenoidectomy for Otitis Media in 2-3 Year Old Children

Stopped early · Phase 3

Conditions studied: Otitis Media With Effusion

In brief

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.

Key facts

Study ID

NCT00016497

Run by

National Institute on Deafness and Other Communication Disorders (NIDCD)

Starts

1997-02-01

Expected to finish

2007-01-01

Last updated by the study team

2006-04-24

Who can join

Age: 2 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

Where it is running

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

Full record on ClinicalTrials.gov

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