After the first few months of life and throughout early childhood, one of the most common pediatric illnesses is ear infection (otitis media). While otitis media usually resolves with or without antibiotics, many children have recurrent episodes and fluid accumulation in the middle ear. The fluid may persist without signs or symptoms of acute infection or inflammation (otitis media with effusion, OME) .
The peak age incidence of OME is during the first 2 years of life [22,23] and more than 90% of infants aged 2 months to 2 years will have one or more episodes of OME . Prospective studies of 2 to 4-year-old children reveal that 50% or more of OMEs resolve within 3 months [25,26] and 95% resolve within 1 year . However, there continues to be concern about significant hearing problems associated with OME and delay in speech and language acquisition.
Ongoing controversy exists as to the best management of these young children with recurrent otitis and OME. Surgical treatment consists of myringotomy with insertion of a small tube through the tympanic membrane. It is the most common surgical procedure among infants and young children . During the first 3 years of life the overall prevalence is 21 per 1000 children in the USA . The primary goal of PE tube insertion is to remove middle ear effusion, prevent fluid accumulation and thus restore hearing, reduce recurrence of infections and prevent developmental delays in speech, language and cognition. The complications and sequelae of tympanostomy tube insertion have been examined by various studies, including one meta-analysis [22,29,30]. They include ear drum perforation, altered membrane appearance or tympanosclerosis (51%), otorrhea (risk of 13%), and cholesteatoma (rare, occurring 10 to 20 years later). While these complications may be noted in children with OME who do not undergo surgery, they are seen more frequently in children who had tube insertion . Most randomized clinical trials of OME provide only short-term follow-up (days to weeks).
Insertion of tubes results in significant short-term improvement in hearing. However, the long-term sequelae are not fully understood. Outcomes of various therapies are evaluated using different measurements of OME resolution (otoscopic findings and tympanometry) and hearing assessments (audiometry). Few have adequately assessed the developmental outcomes and disabilities for these young children over longer periods of follow-up. There is no consistent, reliable scientific evidence that strongly links OME with these long-term sequelae. The decision to treat a child with OME will depend on the duration and severity of the problem as well as the age of the child (which may affect the likelihood of associated developmental problems) and comorbid conditions (e.g. a craniofacial defect, such as cleft palate) . Research supports the use of tympanostomy tubes to treat high-risk children who have persistent OME with recurrent bouts of acute otitis media, bilateral hearing loss (hearing loss of 20 dB or more) with developmental delay and behavior problems, and more complicated disease (e.g. OME with severe tympanic membrane retraction pockets). It remains controversial when and whether to use tympanostomy tubes in healthy young children who have OME. One large randomized clinical trial (RCT) looked at early vs. late tube placement for persistent OME in young children (mean age less than 18 months) and found that the earlier treated group had significantly fewer problems with effusion immediately after surgery, but found no differences in long-term developmental outcome . These authors extended their study to 6 year-old children and still found that tympanostomy tubes did not improve developmental outcomes for school-age children . Another large RCT looked at the effect of early tube insertion vs. observation alone in children (mean age, three years) with outcome assessments of hearing loss and behavior. They reported some short-term, but no long-term, benefits . Because of increasing evidence suggesting that there are no long-term gains for healthy children, the Agency for Healthcare Policy and Research (now known as the Agency for Healthcare Research and Quality) recommended tympanostomy tube insertion only after months of observation [34,35].
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