Objective: In a long-term, prospective study, we set out to determine whether otitis media in the first 3 years of life persisting for periods currently considered developmentally threatening actually results in later impairments of children's cognitive, language, speech, or psychosocial development; whether prompt insertion of tympanostomy tubes prevents or lessens any such impairments; and whether, irrespective of causality, associations exist between persistent early-life otitis media and later developmental impairments. This report describes findings in study participants at the age of 4 years.
Methods: We enrolled 6350 healthy infants from 2 to 61 days of age at urban hospitals and 2 small-town/rural and 4 suburban private pediatric practices. We regularly evaluated the children for the presence of middle-ear effusion (MEE) throughout their first 3 years of life by pneumatic otoscopy, supplemented by tympanometry; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. In the clinical trial component of the study, we randomly assigned 429 children who met specified minimum criteria regarding the persistence of MEE to undergo tympanostomy tube insertion either promptly or after a defined extended period if MEE remained present. In the associational component of the study, we selected a representative sample of 241 children who ranged from having no MEE to having MEE the cumulative duration of which fell just short of meeting randomization criteria for the clinical trial. In 397 (92.5%) of the children in the clinical trial and in 234 (97.1%) of the children in the representative sample, we assessed cognitive, language, speech, and psychosocial development at the age of 4 years, using formal tests, conversational samples, and parent questionnaires.
Results: In children in the randomized clinical trial, there were no statistically significant differences in mean (+/-standard deviation) scores (higher denotes more favorable) favoring the early-treatment group over the late-treatment group on the General Cognitive Index of the McCarthy Scales of Children's Abilities (97 +/- 14 and 98 +/- 14, respectively); the Peabody Picture Vocabulary Test-Revised, a measure of receptive language (90 +/- 15 vs 92 +/- 16); the Nonword Repetition Test, a measure of phonological memory (66 +/- 12 vs 70 +/- 12); the Number of Different Words, a measure of word diversity (150 +/- 34 vs 150 +/- 31); the Mean Length of Utterance in Morphemes, a measure of sentence length and grammatical complexity (3.4 +/- 0.8 vs 3.4 +/- 0.7); or the Percentage of Consonants Correct-Revised, a measure of speech-sound production (92 +/- 5 vs 93 +/- 5). There were also no significant differences in ratings (higher denotes less favorable) on the Parenting Stress Index-Short Form (Total Stress scores: 68 +/- 18 vs 65 +/- 17) or the Child Behavior Checklist (Total Problem T scores: 50 +/- 10 vs 49 +/- 10). In the associational component of the study, correlations between the children's durations of MEE and their developmental outcomes were generally weak and, in most instances, nonsignificant. Exceptions, after adjustment for sociodemographic variables and for hearing thresholds at the time of developmental testing, consisted of a significant negative correlation between children's cumulative durations of MEE in their first 3 years of life and scores on the McCarthy Verbal subscale, and significant positive correlations between durations of MEE and scores on 2 measures of parent-child stress. The percentage of variance in these scores explained by time with MEE beyond that explained by sociodemographic variables ranged from 1.6% to 3.3%. In both the randomized clinical trial and the associational component, sociodemographic variables seemed to be the most important factors influencing developmental outcomes, and in both components, the results at 4 years of age were consistent with the results that had been obtained at 3 years of age.
Conclusions: In otherwise healthy children who are younger than 3 years and have persistent MEE within the duration limits that we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at 4 years of age. In such children, persistent MEE within the duration limits that we studied is negligibly associated with and probably does not affect developmental outcomes at 4 years of age.