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This prospective, randomized study was conducted by University of Pittsburgh investigators to determine whether early or late insertion of tympanostomy tubes in children with persistent otitis media had any effect on their developmental outcomes. A persistent effusion was defined as 90 days for a unilateral effusion and 135 days for a bilateral effusion. Four hundred and twenty-nine children who had persistent middle ear effusion were randomized (mean age 15 months) to undergo insertion of tympanostomy tubes at the earliest possible date (216 children), or to undergo insertion of tympanostomy tubes 6 to 9 months later (213 children) if the effusion persisted. Middle ear and hearing status were followed serially and, at age 3, speech and language, cognition …
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