Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years.

Background: A main indication for the insertion of tympanostomy tubes in in fants and young children is persistent otitis media with effusion, reflecti ng concern that this condition may cause lasting impairments of speech, lan guage, cognitive, and psychosocial development. However, evidence of such r elations is inconclusive, and evidence is lacking that the insertion of tym panostomy tubes prevents developmental impairment. Methods: We enrolled 6350 healthy infants from 2 to 61 days of age and eval uated them regularly for middle-ear effusion. Before the age of three years 429 children with persistent effusion were randomly assigned to have tympa nostomy tubes inserted either as soon as possible or up to nine months late r if effusion persisted. In 402 of these children we assessed speech, langu age, cognition, and psychosocial development at the age of three years. Results: By the age of three years, 169 children in the early-treatment gro up (82 percent) and 66 children in the late-treatment group (34 percent) ha d received tympanostomy tubes. There were no significant differences betwee n the early-treatment group and the late-treatment group at the age of thre e years in the mean (+/-SD) scores on the Number of Different Words test, a measure of word diversity (124+/-32 and 126+/-30, respectively); the Perce ntage of Consonants Correct-Revised test, a measure of speech-sound product ion (85+/-7 vs. 86+/-7); the General Cognitive Index of McCarthy Scales of Children's Abilities (99+/-14 vs. 101+/-13); or on measures of receptive la nguage, sentence length, grammatical complexity, parent-child stress, and b ehavior. Conclusions: In children younger than three years of age who have persisten t otitis media, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at the age of three years. (N Engl J Med 200 1;344:1179-87.) Copyright (C) 2001 Massachusetts Medical Society.