Does the recommendation to use a pacifier influence the prevalence of breastfeeding? Pacifier use, early weaning, and cry/fuss behavior: a randomized controlled trial. UNICEF/WHO baby-friendly hospital initiative: does the use of bottles and pacifiers in the neonatal nursery prevent successful breastfeeding? Neonatal Study Group.
To evaluate whether the recommendation to offer a pacifier once lactation is well established reduces the prevalence or duration of breastfeeding.
                A multicenter, randomized, non-inferiority, controlled trial comprising 1021 mothers highly motivated to breastfeed whose newborns regained birth weight by 15 days. They were assigned to offer versus not to offer pacifiers. Primary outcome was prevalence of exclusive breastfeeding at 3 months. Main secondary outcomes were the prevalence of exclusive and any breastfeeding at different ages and duration of any breastfeeding.
                At 3 months, 85.8% infants in the offer pacifier group and 86.2% in the not offer pacifier group were exclusively breastfeeding (risk difference, 0.4%; 95% CI, -4.9%-4.1%), satisfying the pre-specified non-inferiority requirement of -7%. Furthermore, the recommendation to offer a pacifier did not produce a significant decrease in the frequency of exclusive and any breastfeeding at different ages or in the duration of lactation.
                The recommendation to offer a pacifier at 15 days does not modify the prevalence and duration of breastfeeding. Because pacifier use is associated with reduced incidence of sudden infant death syndrome, the recommendation to offer a pacifier appears safe and appropriate in similar populations. 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.
                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.
                Double-blind, randomized controlled trial conducted from January 1998 to August 1999.
                Postpartum unit of a university teaching hospital in Montreal, Quebec.
                A total of 281 healthy, breastfeeding women and their healthy, term singleton infants.
                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.
                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.
                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).
                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. To promote breastfeeding, UNICEF/WHO have launched the "baby-friendly hospital initiative" focusing on hospital care routines during delivery and the first days of life. In industrialised countries, two aspects of the initiative have raised controversy: how do restriction of supplemental feedings and ban of bottles and pacifiers affect long-term breastfeeding performance? From ten centres 602 healthy newborns were randomly assigned either to a UNICEF group with restrictive fluid supplements and avoidance of bottles and pacifiers during the first 5 days of life, or to a standard group with conventional feeding practice. Breastfeeding was encouraged in both groups. The main study endpoints were the prevalences of breast-feeding on day 5, and after 2, 4 and 6 months. Of the newborns 46% violated the UNICEF protocol, mostly because of maternal requests to give a pacifier or supplements by bottle. In the standard group, the drop-out rate was 9.7%. No significant differences in breastfeeding frequency and duration could be found: (UNICEF vs standard) day 5: 100% vs 99%; 2 months: 88% vs 88%; 4 months: 75% vs 71%; 6 months: 57% vs 55%. Inclusion of drop-outs due to pacifier use did not alter the results. Conclusion: In our study population fluid supplements offered by bottle with or without the use of pacifiers during the first 5 days of life were not associated with a lower frequency or shorter duration of breastfeeding during the first 6 months of life.
Pacifier use in healthy term breastfeeding infants, started from birth or after lactation is established, did not significantly affect the prevalence or duration of exclusive and partial breastfeeding up to four months of age. However, evidence to assess the short-term breastfeeding difficulties faced by mothers and long-term effect of pacifiers on infants' health is lacking.