Recruitment and Clinical Follow-Up
AOM, middle-ear effusion
OTITIS MEDIA, ACUTE RESPIRATORY INFECTION, INFLAMMATION OF THE TYMPANIC MEMBRANE
Study physicians visited day care centers to provide families with information about the study. In addition, local child health clinics distributed study information brochures to families. Participants with written informed consent from a legal guardian were included in the study. After this, the participant was given the next available study number and the randomized study product adjoined to it. After enrollment, families were sent an online questionnaire about background characteristics. In Finland, social security number is binomial according to sex. Participants’ sex was calculated from social security number. No ethnicity data was collected.Study physicians reviewed all purchases of antimicrobials from the comprehensive electronic national prescription register during the 6 months of follow-up.The diagnosis of AOM was defined according to the national AOM treatment guideline as an acute, short-term, and clinically diagnosed episode of otitis media, with the presence of middle-ear effusion, signs of inflammation of the tympanic membrane, and at least 1 sign or symptom of an acute respiratory infection.