Early placement of tympanostomy tubes does not improve developmental outcomes in normal children

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• Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Rockette HE, Pitcairn DL, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007;356:248-61
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Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Rockette HE, Pitcairn DL, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007;356:248-61 

Question Among children with persistent middle ear effusion, does prompt insertion of tympanostomy tubes improve developmental outcomes?

Design Prospective study.

Setting Children were recruited from two Pittsburgh area hospitals and six group practices.

Participants 6350 infants were enrolled soon after birth. 429 children were followed over the course of the study.

Intervention Before 3 years of age, 429 children with persistent effusion were randomly assigned to undergo the insertion of tympanostomy tubes either promptly or up to 9 months later if effusion persisted.

Outcomes Literacy, attention, social skills, and academic achievement at 9 to 11 years of age.

Main Results Mean (±SD) scores on 48 developmental measures in the group of children who were assigned to undergo early insertion of tympanostomy tubes did not differ significantly from the scores in the group that was assigned to undergo delayed insertion. These measures included the Passage Comprehension subtest of the Woodcock Reading Mastery Tests (mean score, 98±12 in the early-treatment group and 99±12 in the delayed- treatment group); the Spelling, Writing Samples, and Calculation subtests of the Woodcock–Johnson III Tests of Achievement (96±13 and 97±16; 104±14 and 105±15; and 99±13 and 99±13, respectively); and inattention ratings on visual and auditory continuous performance tests.

Conclusions In otherwise healthy young children who have persistent middle-ear effusion, as defined in this study, prompt insertion of tympanostomy tubes does not improve developmental outcomes up to 9 to 11 years of age.

Commentary Recognizing the deficiencies of prior retrospective studies, Paradise and colleagues designed a prospective study to determine if there is a causal relationship between early otitis media with effusion (OME) and later impairments of speech, language, and cognitive development. The study findings failed to identify an association between early otitis media and later impairments, even after 9-11 years. These new findings are important because they provide reassurance that developmental impairments that are not identified at an earlier age do not come into play later in the setting of greater academic challenges. When the analyses from the observational cohort at the follow-up periods were adjusted for demographic variables including socioeconomic status, there were either no significant correlations between effusion duration and outcome test scores or the effect size (percent of variance) related to the effusion duration was clinically meaningless. Since a hearing loss of 40 decibels or higher was quite uncommon among subjects in the study of Paradise et al, it could not address whether this level of hearing loss also leads to impairments. Likewise, the study does not address the question of whether ventilating tubes will help children with preexisting language or other developmental delays. The 2004 OME guideline¹ recommends the following approach to persistent middle ear effusion: Determine during visits the laterality and duration of the effusion and the child’s non-otitis related risk for a speech, language or learning problem. In otherwise normal children, perform a hearing test when the effusion has been present for 3 months and continue with “watchful waiting” at 3 to 6 month intervals until the effusion clears. Refer for ventilating tubes when there is a bilateral hearing loss of 40 decibels or higher, a speech or language delay, or structural abnormalities of the eardrum develop.

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Reference 

1. American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Clinical practice guideline: otitis media with effusion. Pediatrics. 2004;113:1412–1429
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