Objective: As part of a prospective study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between children's cumulative duration of middle ear effusion (MEE) in their first 3 years of life and their scores on measures of language, speech sound production, and cognition at 3 years of age.
Methods: We enrolled 6350 healthy infants by 2 months of age who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small town/rural and 4 suburban private pediatric practices. We intensively monitored the children's middle ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. Children who met specified minimum criteria regarding the persistence of MEE became eligible for a clinical trial in which they were assigned randomly to undergo tympanostomy tube placement either promptly or after a defined extended period if MEE remained present. From among those remaining, we selected randomly, within sociodemographic strata, a sample of 241 children who represented a spectrum of MEE experience from having no MEE to having MEE whose cumulative duration fell just short of meeting randomization criteria. In subjects so selected, the estimated duration of MEE ranged from none to 65.6% of the first year of life and 44.8% of the first 3 years of life. In these 241 children we assessed language development, speech sound production, and cognition at 3 years of age, using both formal tests and conversational samples.
Results: We found weak to moderate, statistically significant negative correlations between children's cumulative durations of MEE in their first year of life or in age periods that included their first year of life, and their scores on formal tests of receptive vocabulary and verbal aspects of cognition at 3 years of age. However, the percent of variance in these scores explained by time with MEE in the first year of life beyond that explained by sociodemographic variables ranged only from 1.2% to 2.9%, and the negative correlations were concentrated in the subgroup of children whose families had private health insurance (rather than Medicaid). We found no significant correlations in the study population as a whole or in any subgroup between time with MEE during antecedent periods and children's scores on measures of spontaneous expressive language, speech sound production, or other measured aspects of cognition. In contrast, by wide margins, scores on all measures were consistently highest among the most socioeconomically advantaged children and lowest among the most socioeconomically disadvantaged children.
Conclusions: Our findings suggest either that persistent early-life MEE actually causes later small, circumscribed impairments of receptive language and verbal aspects of cognition in certain groups of children or that unidentified, confounding factors predispose children both to early-life otitis media and to certain types of developmental impairment. Findings in the randomized clinical trial component of the larger study should help distinguish between causality and confounding as explanations for our findings.language, speech, cognition, development, otitis media, middle ear effusion.