ABSTRACT. Objective. We followed a cohort (N ؍ 306) of infants at well-baby visits in two suburban pediatric practices to assess the relation of exclusive breastfeeding, and other environmental exposures, to episodes of acute otitis media (AOM) and otitis media with effusion (OME).Methods. Detailed prospective information about the exclusiveness of breastfeeding, parental smoking, day care attendance, and family history was obtained at scheduled clinic visits. Tympanometric and otoscopic examinations were used in the diagnosis of otitis media (OM). Nasopharyngeal cultures were performed at 1-6 months, and at 8, 10, 12, 15, 18, and 24 months of age to detect colonization with middle-ear pathogens.Results. Between 6 and 12 months of age, cumulative incidence of first OM episodes increased from 25% to 51% in infants exclusively breastfed and from 54% to 76% in infants formula-fed from birth. Peak incidence of AOM and OME episodes was inversely related to rates of breastfeeding beyond 3 months of age. A twofold elevated risk of first episodes of AOM or OME was observed in exclusively formula-fed infants compared with infants exclusively breast-fed for 6 months. In the logistic regression analysis, formula-feeding was the most significant predictor of AOM and OME episodes, although age at colonization with middle-ear pathogens and day care (outside the home) were significant competing risk factors. A hazard health model suggested additionally that breastfeeding, even for short durations (3 months), reduced onset of OM episodes in infancy.Conclusions. Modifiable factors in the onset of AOM and OME episodes during the first 2 years of life include early age at colonization (<3 months of age), day care outside the home, and not being breastfed. Pediatrics 1997;100(4). URL: http://www.pediatrics.org/cgi/content/ full/100/4/e7; acute otitis media; otitis media with effusion; nasopharyngeal colonization; breastfeeding; day care; proportional hazards.ABBREVIATIONS. AOM, acute otitis media; OME, otitis media with effusion; OM, otitis media; CI, confidence interval; RR, relative risk.D espite general agreement that breastfeeding moderates gastrointestinal and respiratory infections in childhood, many questions underlying the beneficial effects of breast milk in preventing acute otitis media (AOM) and otitis media with effusion (OME) remain unanswered. Design issues and sample size variation account for much of the variability reported. Summarized in Table 1, recent studies in well-defined cohorts have yielded equivocal results. Among 5356 infants in Turku, Finland, followed for 1 year, those with breastfeeding durations of Ͻ9 months were associated with a 30% to 50% elevated risk of developing otitis media (OM). 1 A cohort of 1661 infants born in Dunedin, New Zealand, were assessed at 3 years of age; after adjustment for number of siblings, type of day care, and passive smoking, duration of breastfeeding was associated with reduced prevalence of OM disease, but the difference was not significant. 2 In Greater Boston, among ...