A rotavirus outbreak in newborns admitted to the 'La Paz' University Hospital, Madrid was detected, followed up and controlled. Uninfected children were selected as control subjects. Samples of faeces were taken once or twice weekly from all the newborns, including those who were asymptomatic and who were admitted to the neonatal unit for early detection of rotavirus and the positive were separated from the rest of the neonates. Contact-related precautions were taken for all patients, and alcohol solutions were used for hand washing. During the months of the outbreak, 1773 children were admitted to the hospital, 131 of whom were affected by the rotavirus infection (7.4%). Of these, 72 (55%) had symptomatic infections. In the first month of the outbreak, nine cases of necrotizing enterocolitis were diagnosed (one patient developed massive intestinal necrosis). The infections (symptomatic and asymptomatic) presented a bimodal distribution caused by a new outbreak of rotavirus type P4G2 after two patients who had acquired the infection outside the hospital were admitted when the first outbreak was subsiding. The characteristics of cases and controls were analysed using bivariate and multivariate methods (non-conditional multivariate logistic regression) to identify four risk factors strongly associated with rotavirus infection: premature birth, infections other than rotavirus, malformation, and changes in glycaemia and/or presence of jaundice.