Pacifier use, early weaning, and cry/fuss behavior - A randomized controlled

Context The World Health Organization and the United Nations Children's Fun d strongly discourage use of pacifiers because of their perceived interfere nce with breastfeeding, Observational studies have reported a strong associ ation between pacifier use and early weaning, but such studies are unable t o determine whether the association is causal. Objectives To test whether regular pacifier use is causally related to wean ing by 3 months postpartum and to examine differences in results according to randomized intervention allocation vs observational use or nonuse of pac ifiers. Design Double-blind, randomized controlled trial conducted from January 199 8 to August 1999. Setting Postpartum unit of a university teaching hospital in Montreal, Queb ec. Participants A total of 281 healthy, breastfeeding women and their healthy, term singleton infants. Interventions Participants were randomly allocated to 1 of 2 counseling int erventions provided by a research nurse trained in location counseling. The experimental intervention (n=140) differed from the control (n=141) by rec ommending avoidance of pacifier use and suggesting alternative ways to comf ort a crying or fussing infant, Main Outcome Measures Early weaning, defined as weaning within the first 3 months, compared between groups; 24-hour infant behavior logs detailing fre quency and duration of crying, fussing, and pacifier use at 4, 6, and 9 wee ks. Results A total of 258 mother-infant pairs (91.8%) completed follow-up. The experimental intervention increased total avoidance of pacifier use (38.6% vs 16.0% in the control group), reduced daily use (40.8% vs 55.7%), and de creased the mean number of pacifier insertions per day (0.8 vs 2.4 at 4 wee ks [P<.001]; 0.8 vs 3.0 at 6 weeks [P<.001]; and 1.3 vs 3.0 at 9 weeks [P=. 004]). In the analysis based on randomized intervention allocation, the exp erimental intervention had no discernible effect on weaning at 3 months (18 .9% vs 18.3% in the experimental vs control group; relative risk [RR], 1.0; 95% confidence interval [CI], 0.6-1.7), and no effect was observed on cry/ fuss behavior tin the experimental vs control groups, respectively, total daily duration, 143 vs 151 minutes at 4 weeks [P=.49]; 128 vs 131 minutes a t 6 weeks [P=.81]; and 110 vs 104 minutes at 9 weeks [P=.58]). When randomi zed allocation was ignored, however, we observed a strong observational ass ociation between exposure to daily pacifier use and weaning by 3 months (25 .0% vs 12.9% of the exposed vs unexposed groups; RR, 1.9, 95% CI, 1.1-3.3). Conclusions We found a strong observational association between pacifier us e and early weaning. No such association was observed, however, when our da ta were analyzed by randomized allocation, strongly suggesting that pacifie r use is a marker of breastfeeding difficulties or reduced motivation to br eastfeed, rather than a true cause of early weaning.