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Burden of Respiratory Syncytial Virus Infection During the First Year of Life. BACKGROUND: Although many infants with respiratory syncytial virus (RSV) infection are hospitalized, most infants are treated as outpatients. Limited data are available on the burden of RSV in outpatient infants. METHODS: In a prospective study, we enrolled 431 newborn infants and followed them up for a 10-month period (September-June). During each respiratory illness, we examined the infants and obtained nasopharyngeal specimens for the detection of RSV. The parents completed daily symptom diaries throughout the study. RESULTS: Among 408 active participants, the seasonal incidence rate of RSV illness was 328.4 per 1000 (95% confidence interval [CI], 275.2-389.0). Infants with ≥1 sibling had a 1.9-fold higher incidence of RSV illness than those without siblings (95% CI, 1.3-2.8; P < .001). Acute otitis media developed in 103 (76.9%) of 134 infants with RSV infection, and 95 (70.9%) were treated with antibiotics. Nine infants with RSV (6.7%) were hospitalized, for a seasonal incidence rate of RSV hospitalization of 22.1 per 1000 (95% CI, 10.1-41.9). CONCLUSIONS: The outpatient burden of RSV is heavy on infants during the first year of life. Acute otitis media is a frequent complication of RSV, and it should be included in cost-effectiveness analyses of prevention or treatment of RSV infections in infants.