OBJECTIVE To study the association between birth characteristics and the recurrence of otitis media with effusion (OME). METHODS Prospective cohort study on 136 children aged 2-7 years, who received tympanostomy tubes for bilateral otitis media with effusion. Checkups were planned 1 week after tube insertion and once every 3 months thereafter. An otologist examined the ear status to assess tube extrusion and otitis media with effusion recurrence. Outcome measure was the recurrence of otitis media with effusion within 6 months after documentation of spontaneous tube extrusion. Birth characteristics were investigated in relation with the recurrence of otitis media with effusion in 90 children with known clinical outcome. RESULTS No statistically significant associations were found between various birth characteristics and the recurrence of otitis media with effusion. Multivariate analyses showed positive but fairly weak associations between recurrence of otitis media with effusion and low birth weight (<2500 g) and/or low gestational age (<37 weeks) and/or a history of incubator care (odds ratio (OR) 1.95, 95% confidence interval (CI): 0.21-18.2), male sex (OR 1.85, 95% CI: 0.56-6.13) and maternal medication use during pregnancy (OR 4.80, 95% CI: 0.57-40.72). A remarkable finding was the asymmetrical distribution of certain birth characteristics within the group of children with recurrence of otitis media with effusion: children with unilateral recurrence had a relatively lower gestational age, lower birth weight, lower 'birth length to birth weight' ratio than the children with bilateral recurrence. CONCLUSION These findings suggest that determination of birth characteristics cannot help us in the treatment strategy for recurrent otitis media with effusion in childhood.