Acute otitis media in early infancy. Recurrence and prophylaxis.

During a four-year period, two groups of patients were observed for recurrences of bouts of acute otitis media (AOM) after initial episodes of AOM in early infancy. Of 19 infants with a first bout of AOM before 3 months of age, all had at least one recurrence within eight months, of them 15 (79%) within four months. All members of a second group of 37 infants with two bouts of AOM before 12 months of age had a third bout within 14 months, and 28 of them (76%) had a recurrence within four months. During the ensuing two years (phase two), a group of 6 infants with one bout of AOM before 3 months of age (group one) and a group of 25 infants with two bouts of AOM before 12 months of age (group two) were treated for four months with 25 mg/kg/day aminopenicillin as a single oral daily dose. There were no episodes of AOM in these infants during the prophylactic period. During a third phase lasting two years, patients were assigned to treatment or no treatment regimens for four-month periods. Patients in treatment regimens received aminopenicillin or erythromycin ethylsuccinate-sulfamethoxazole (EES-SMZ) once daily. In infants with one bout of AOM before 3 months (Group 1) there were seven bouts of AOM in 9 untreated vs. one bout in 13 treated patients. In the group of infants with two bouts of AOM before 12 months (Group 2), 13 untreated infants had six bouts of AOM vs. no bouts in 19 treated patients.

RCT Entities:   Population Interventions Outcomes