Pacifier use, early weaning, and cry/fuss behavior: a randomized controlled trial.

CONTEXT

The World Health Organization and the United Nations Children's Fund strongly discourage use of pacifiers because of their perceived interference with breastfeeding. Observational studies have reported a strong association between pacifier use and early weaning, but such studies are unable to determine whether the association is causal.

OBJECTIVES

To test whether regular pacifier use is causally related to weaning by 3 months postpartum and to examine differences in results according to randomized intervention allocation vs observational use or nonuse of pacifiers.

DESIGN

Double-blind, randomized controlled trial conducted from January 1998 to August 1999.

SETTING

Postpartum unit of a university teaching hospital in Montreal, Quebec.

PARTICIPANTS

A total of 281 healthy, breastfeeding women and their healthy, term singleton infants.

INTERVENTIONS

Participants were randomly allocated to 1 of 2 counseling interventions provided by a research nurse trained in location counseling. The experimental intervention (n = 140) differed from the control (n = 141) by recommending avoidance of pacifier use and suggesting alternative ways to comfort 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 frequency and duration of crying, fussing, and pacifier use at 4, 6, and 9 weeks.

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 decreased the mean number of pacifier insertions per day (0.8 vs 2.4 at 4 weeks [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 experimental 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 (in the experimental vs control groups, respectively, total daily duration, 143 vs 151 minutes at 4 weeks [P =.49]; 128 vs 131 minutes at 6 weeks [P =.81]; and 110 vs 104 minutes at 9 weeks [P =.58]). When randomized allocation was ignored, however, we observed a strong observational association 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 use and early weaning. No such association was observed, however, when our data were analyzed by randomized allocation, strongly suggesting that pacifier use is a marker of breastfeeding difficulties or reduced motivation to breastfeed, rather than a true cause of early weaning.