Pacifier As a Risk Factor for Acute Otitis Media: A Randomized, Controlled Trial of Parental Counseling

Objectives: To evaluate the association between pacifier use and the increased occurrence of acute otitis media (AOM) in an intervention trial.

Methods: Fourteen well-baby clinics were selected to participate in an open, controlled cohort study. These clinics were paired according to the number of children and the social classes of the parents they served. One clinic in each pair was randomly allocated for an intervention, while the other served as a control. The nurses at the intervention clinics were trained to instruct the parents of children <18 months old to limit pacifier use during their prescheduled visits to the clinic. The intervention consisted of a leaflet explaining the harmful effects of pacifier use and instructions to restrict its use. Two hundred seventy-two children were successfully recruited from the intervention clinics and 212 from the control clinics. The data about pacifier use and the occurrence of respiratory infections and AOM were collected similarly in both groups.

Results: After the intervention, a 21% decrease was achieved in continuous pacifier use at the age of 7 to 18 months (P =.0001), and the occurrence of AOM per person-months at risk was 29% lower among children at the intervention clinics. The children who did not use a pacifier continuously in either of the clinics had 33% fewer AOM episodes than the children who did.

Conclusion: Pacifier use appeared to be a preventable risk factor for AOM in children. Its restriction to the moments when the child was falling asleep effectively prevented episodes of AOM.