This application is for continuing support of a study, begun in 1991, whose main objectives are to determine 1) whether persistent otitis media with effusion (OME) occurring at common levels of frequency and duration during the first 3 years of life impairs later speech, language, cognitive, or psychosocial development; and 2) whether prompt tympanostomy-tube placement (TTP) prevents or lessens any such impairments. Major elements of this study and much analysis have been completed. Over a 4 1/2-year period we enrolled a diverse sample of 6350 normal infants by age 2 mo at 2 urban hospitals and 6 private pediatric practices, and we intensively monitored their middle-ear status prospectively. Of the 6350 children, 429 met specified criteria regarding persistent OME in the first 3 years of life and were randomized to receive TTP either promptly or after a defined extended period if OME persisted. In addition, 241 children who represented a spectrum from having no MEE to having MEE whose cumulative duration and/or sequencing fell just short of meeting randomization criteria were selected randomly and within sociodemographic strata for an associational study. Attrition in these two groups has been low. Our study 1) has shown that in children with persistent early-life OME within the duration limits we studied, prompt TTP does not improve a range of developmental outcomes at age 3 yr or, to the extent results are available, at age 4 yr; and 2) has provided strong evidence against a causal relationship between early-life OME, within those duration limits, and developmental impairment at age 3 yr and, to the extent that results are available, at age 4 years. Nonetheless it remains important to determine whether early-life OME has unfavorable developmental consequences for 6-year-old children, who are faced with additional cognitive, speech, language, and psychosocial demands as they enter school, and in whom impairments may be more readily detectable than at earlier ages. Our sole specific aim for the present application is to answer the two questions above with respect to our subjects at age 6 yerrs. Our youngest subjects will be eligible for age 6 yr testing early in 2002, and transcription and analysis of all age 6 yr language samples, and the ensuing attendant data reduction, data analysis, and manuscript preparation will require 9 additional months. This study will provide new knowledge that will make possible more rational, evidence-based management of otitis media in young children, and will thereby benefit children and substantially influence child health care practices and costs.
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