Efficacy of adenoidectomy for the treatment and prevention of otitis media with effusion has been shown for children four years and older. In their """"""""Clinical Practice Guidelines, Otitis Media with Effusion in Young Children"""""""", the Agency for Health Care Policy and Research of the U.S. Department of Health and Human Services concluded that """"""""Adenoidectomy is not recommended for treatment of OME in a child age 1 through 3 years in the absence of specific adenoid pathology"""""""". This conclusion was based on the Panel's finding no clinical trials to support any judgement as to the efficacy of adenoidectomy in the primary management of otitis media with effusion in very young children, coupled with the risk of postoperative bleeding. By means of a well designed large-scale randomized controlled trial, the efficacy of adenoidectomy and myringotomy with and without tympanotomy tube insertion will be compared with that of myringotomy and tympanotomy alone in reducing the morbidity of bilateral otitis media with effusion of at least 3 months's duration associated with hearing loss (>20 dB) in children ages 2 and 3 years. The primary outcome measure will be percentage of time with middle ear effusion. Rates of episodes of acute otitis media, otorrhea, and otitis media with effusion, time to first recurrence, number of surgical procedures, treatment failures, hearing status, and other sequelae and complications will be recorded and compared among the three treatment groups. We estimate that 63 evaluable subjects need to be entered in each treatment arm to have a 90 percent power of detecting a benefit of at least 0.30 in percentage of time with middle ear effusion. The outcome of this trial should resolve the question of efficacy of adenoidectomy for otitis media with effusion in this age group.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Research Project (R01)
Project #
5R01DC003205-03
Application #
2872138
Study Section
Hearing Research Study Section (HAR)
Project Start
1997-02-01
Project End
2002-01-31
Budget Start
1999-02-01
Budget End
2000-01-31
Support Year
3
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Children's Hosp Pittsburgh/Upmc Health Sys
Department
Type
DUNS #
044304145
City
Pittsburgh
State
PA
Country
United States
Zip Code
15224
Casselbrant, Margaretha L; Mandel, Ellen M; Rockette, Howard E et al. (2009) Adenoidectomy for otitis media with effusion in 2-3-year-old children. Int J Pediatr Otorhinolaryngol 73:1718-24