IHEARBETA Primary outcomes

Demographics - Location (by Northern Territory region) - Ethnicity (all Australian First Nations) Baseline / randomisation characteristics (Table 1 in publication) - Birth characteristics (birth weight, gestational age, maternal smoking) - Randomisation characteristics (weight, age, breastfeeding status, household smoking, environmental smoke, family history 'runny ears') Randomisation allocation (treatment group) and treatment given Otitis media diagnosis at baseline, 16 weeks (primary outcome) and 12 months. Additional antibiotic management data (clinical failure) in the 16 week intervention period. Primary outcome hearing data. Basic microbiologic data from ear discharge.