A new study reports that in otherwise healthy children younger than 3 years of age who have persistent middle-ear effusion, early insertion of tympanostomy tubes does not improve developmental outcomes by age 6. The randomized controlled clinical trial, which met the highest standards of evidence-based practice, produced a result at odds with the commonly accepted principle that improving hearing early on combats any adverse effects on childhood development associated with poor hearing.
The study, published in the Aug. 11 New England Journal of Medicine, was a joint project with contributions from several departments at the University of Pittsburgh and from Children's Hospital of Pittsburgh. It expanded on a previous report that early insertion of tympanostomy tubes in children younger than age 3 did not result in improved developmental outcomes at age 4. However, the effect on the outcomes of school-age children was unknown.
The study enrolled 6,350 healthy infants younger than 62 days of age and evaluated them regularly for middle-ear effusion. Then, 429 children younger than age 3 with persistent middle-ear effusion were randomly assigned either to have tympanostomy tubes inserted promptly or up to nine months later. The developmental outcomes in 395 of the children were then assessed at age 6.
By 6 years of age, 85% of children in the early-treatment group and 41% in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient.
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