This study will investigate whether persistent otitis media with effusion (OME) during children's first 3 years of life results in impairments at ages 9 to 11 years of their literacy, attentional abilities, or related skills, and if so, whether prompt tympanostomy-tube placement (TTP) is efficacious in preventing or lessening such impairments. The proposed study builds on a current study that assesses relations between persistent middle-ear effusion (MEE) in early life, TTP, and speech, language, cognitive, and psychosocial development at ages 3, 4, and 6 yr. In that study, a diverse sample of 6350 normal infants was enrolled by age 2 months and their middle-ear status was intensively monitored prospectively. Three cohorts of subjects from the current study will constitute the subjects of the proposed study. One cohort consists of 429 children in whom MEE had persisted for extended periods of specified duration during the first 3 years of life and who on that basis were randomly assigned to receive either prompt TTP, or delayed TTP after a specified period if their MEE persisted. The second cohort consists of 152 children who met the criteria for randomization but whose parents withheld permission for randomization. The third cohort consists of a sample of 241 enrolled children who represented a spectrum ranging from no MEE in the first 3 years of life to having durations of MEE just short of meeting the randomization criteria. Findings to date indicate no measurable impact of MEE, within the duration limits studied, on the developmental outcomes measured in these cohorts at ages 3 and 4 years. Nonetheless, developmental assessment of the three cohorts at age 9, 10, or 11 yr is important for 4 reasons: (1) Current, official guidelines recommending performance of TTP in young children are based, in part, on reports that persistent MEE in early life results in impairments of literacy, attentional abilities, and related skills when children reach school age. However, the studies concerned have had important limitations and their results are questionable. (2) Relations that were not apparent in our current study at ages 3 or 4 might become apparent at later ages. (3) Our current study, which ends at age 6 yr, does not include measures of literacy or attentional abilities. (4) The 3 cohorts constitute a valuable and unique population for study that can be replicated only at great cost. The proposed study will provide new knowledge that will make possible more rational, evidence-based management of otitis media, and thereby benefit children and substantially influence child health care practices and costs.
