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Clinical Trial
. 2005 Aug 11;353(6):576-86.
doi: 10.1056/NEJMoa050406.

Developmental outcomes after early or delayed insertion of tympanostomy tubes

Jack L Paradise  1 , Thomas F Campbell, Christine A Dollaghan, Heidi M Feldman, Beverly S Bernard, D Kathleen Colborn, Howard E Rockette, Janine E Janosky, Dayna L Pitcairn, Marcia Kurs-Lasky, Diane L Sabo, Clyde G Smith
Affiliations
Clinical Trial

Developmental outcomes after early or delayed insertion of tympanostomy tubes

Jack L Paradise et al. N Engl J Med. .

Abstract

Background: To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. We previously reported that prompt as compared with delayed insertion of tympanostomy tubes in children with persistent effusion who were younger than three years of age did not result in improved developmental outcomes at three or four years of age. However, the effect on the outcomes of school-age children is unknown.

Methods: We enrolled 6350 healthy infants younger than 62 days of age and evaluated them regularly for middle-ear effusion. Before three years of age, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to nine months later if effusion persisted. We assessed developmental outcomes in 395 of these children at six years of age.

Results: At six years of age, 85 percent of children in the early-treatment group and 41 percent in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean (+/-SD) scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient (98+/-13 vs. 98+/-14); Number of Different Words test, a measure of word diversity (183+/-36 vs. 175+/-36); Percentage of Consonants Correct-Revised test, a measure of speech-sound production (96+/-2 vs. 96+/-3); the SCAN test, a measure of central auditory processing (95+/-15 vs. 96+/-14); and several measures of behavior and emotion.

Conclusions: In otherwise healthy children younger than three years of age who have persistent middle-ear effusion within the duration of effusion that we studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at six years of age.

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Figures

Figure 1
Figure 1. Enrollment, Randomization, and Follow-up of the Children and the Time of Insertion of Tympanostomy Tubes
Two of the children who underwent developmental testing at six years of age — one in the early-treatment group of the clinical trial and one in the delayed-treatment group — were not tested at either three or four years of age.
See this image and copyright information in PMC

Comment in

References

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