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. Effect of intervention to improve breastfeeding technique on the frequency of exclusive breastfeeding and lactation-related problems. Nonnutritive sucking modulates behavioral state for preterm infants before feeding. Prolonged and exclusive breastfeeding reduces the risk of infectious diseases in infancy. Evaluation of beneficial effects of nonnutritive sucking in preterm infants. Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus. A randomized controlled trial of sucrose and/or pacifier as analgesia for infants receiving venipuncture in a pediatric emergency department.
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. This randomized clinical trial compared frequencies of exclusive breastfeeding and lactation-related problems during the first 30 days among 74 mothers who received a 30-minute counseling session on breastfeeding technique in the maternity ward, and 137 controls. The frequency of exclusive breastfeeding among mothers who had received intervention was similar to controls by 7 days (79.7% vs 82.5%, respectively) and 30 days (60.8% vs 53.3%). There was no difference between groups in the frequency of sore nipples at 7 and 30 days, in breast engorgement and mastitis, and in the quality of breastfeeding technique at 30 days. Therefore, a single intervention at maternity was not sufficient to improve breastfeeding technique, increase exclusive breastfeeding rates, and reduce the incidence of breastfeeding problems during the first month. Forty-two pre-term infants were studied to determine the effect of nonnutritive sucking pre-feeding on behavioral state. Infants were randomly assigned to pacifier or rest groups. Pacifiers or rest were given for 5 minutes following routine caregiving and before each of the first 16 bottle feedings. A 12-category scale was used to measure state immediately before the 5-minutes and after. Frequencies of states that precede optimal feedings changed for infants given pacifiers versus rest: alert inactivity (+6 vs. -2), quiet awake (+19 vs. -6), and active awake (-24 vs. +12); infants given pacifiers had more sleep and fewer restless states. Group differences were non-significant before nonnutritive sucking (p = 0.16) but significant after (p = 0.00001). When self-regulatory feeding policies based on early hunger cues are not allowed, nonnutritive sucking for 5 minutes pre-feeding is simple, brief, and appropriate for busy intensive care units. These findings confirm those from earlier less conclusive research and indicate that nonnutritive sucking modulates behavioral state. To examine the associations of duration of exclusive breastfeeding with infections in the upper respiratory (URTI), lower respiratory (LRTI), and gastrointestinal tracts (GI) in infancy.
                This study was embedded in the Generation R Study, a population-based prospective cohort study from fetal life onward in the Netherlands. Rates of breastfeeding during the first 6 months (never; partial for <4 months, not thereafter; partial for 4-6 months; exclusive for 4 months, not thereafter; exclusive for 4 months, partial thereafter; and exclusive for 6 months) and doctor-attended infections in the URTI, LRTI, and GI until the age of 12 months were assessed by questionnaires and available for 4164 subjects.
                Compared with never-breastfed infants, those who were breastfed exclusively until the age of 4 months and partially thereafter had lower risks of infections in the URTI, LRTI, and GI until the age of 6 months (adjusted odds ratio [aOR]: 0.65 [95% confidence interval (CI): 0.51-0.83]; aOR: 0.50 [CI: 0.32-0.79]; and aOR: 0.41 [CI: 0.26-0.64], respectively) and of LRTI infections between the ages of 7 and 12 months (aOR: 0.46 [CI: 0.31-0.69]). Similar tendencies were observed for infants who were exclusively breastfed for 6 months or longer. Partial breastfeeding, even for 6 months, did not result in significantly lower risks of these infections.
                Exclusive breastfeeding until the age of 4 months and partially thereafter was associated with a significant reduction of respiratory and gastrointestinal morbidity in infants. Our findings support health-policy strategies to promote exclusive breastfeeding for at least 4 months, but preferably 6 months, in industrialized countries. The effects of nonnutritive sucking (NNS) were studied in 40 preterm infants weighing less than or equal to 1800 g and of less than or equal to 35 weeks gestation by using a pacifier. The provision of NNS accelerated the maturation of sucking resulting in a faster transition from gavage to oral feedings. Treated infants (20) were ready for bottle feeds 1.54 days earlier, took their bottle feeds 1.5 min/30 ml faster and were transferred out of the nursery on an average .5 days earlier than the control infants. No adverse effects due to NNS were observed throughout the period of study. This resulted in an earlier union with their mother, less maternal deprivation and decreased work load on the nursery staff. Used judiciously this simple and safe modality of providing a pacifier for NNS during tube feeding may be useful in the management of preterm infants. Current evidence that breastfeeding is beneficial for infant and child health is based exclusively on observational studies. Potential sources of bias in such studies have led to doubts about the magnitude of these health benefits in industrialized countries.
                To assess the effects of breastfeeding promotion on breastfeeding duration and exclusivity and gastrointestinal and respiratory infection and atopic eczema among infants.
                The Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial conducted June 1996-December 1997 with a 1-year follow-up.
                Thirty-one maternity hospitals and polyclinics in the Republic of Belarus.
                A total of 17 046 mother-infant pairs consisting of full-term singleton infants weighing at least 2500 g and their healthy mothers who intended to breastfeed, 16491 (96.7%) of which completed the entire 12 months of follow-up.
                Sites were randomly assigned to receive an experimental intervention (n = 16) modeled on the Baby-Friendly Hospital Initiative of the World Health Organization and United Nations Children's Fund, which emphasizes health care worker assistance with initiating and maintaining breastfeeding and lactation and postnatal breastfeeding support, or a control intervention (n = 15) of continuing usual infant feeding practices and policies.
                Duration of any breastfeeding, prevalence of predominant and exclusive breastfeeding at 3 and 6 months of life and occurrence of 1 or more episodes of gastrointestinal tract infection, 2 or more episodes of respiratory tract infection, and atopic eczema during the first 12 months of life, compared between the intervention and control groups.
                Infants from the intervention sites were significantly more likely than control infants to be breastfed to any degree at 12 months (19.7% vs 11.4%; adjusted odds ratio [OR], 0.47; 95% confidence interval [CI], 0.32-0.69), were more likely to be exclusively breastfed at 3 months (43.3% vs 6.4%; P<.001) and at 6 months (7.9% vs 0.6%; P =.01), and had a significant reduction in the risk of 1 or more gastrointestinal tract infections (9.1% vs 13.2%; adjusted OR, 0.60; 95% CI, 0.40-0.91) and of atopic eczema (3.3% vs 6.3%; adjusted OR, 0.54; 95% CI, 0.31-0.95), but no significant reduction in respiratory tract infection (intervention group, 39.2%; control group, 39.4%; adjusted OR, 0.87; 95% CI, 0.59-1.28).
                Our experimental intervention increased the duration and degree (exclusivity) of breastfeeding and decreased the risk of gastrointestinal tract infection and atopic eczema in the first year of life. These results provide a solid scientific underpinning for future interventions to promote breastfeeding. Although sucrose has been accepted as an effective analgesic agent for procedural pain in neonates, previous studies are largely in the NICU population using the procedure of heel lance. This is the first report of the effect of sucrose, pacifier or the combination thereof for the procedural pain of venipuncture in infants in the pediatric emergency department population.
                The study design was a double (sucrose) and single blind (pacifier), placebo-controlled randomized trial--factorial design carried out in a pediatric emergency department. The study population was infants, aged 0-6 months. Eighty-four patients were randomly assigned to one of four groups: a) sucrose b) sucrose & pacifier c) control d) control & pacifier. Each child received 2 ml of either 44% sucrose or sterile water, by mouth. The primary outcome measure: FLACC pain scale score change from baseline. Secondary outcome measures: crying time and heart rate change from baseline.
                Sucrose did not significantly reduce the FLACC score, crying time or heart rate. However sub-group analysis revealed that sucrose had a much greater effect in the younger groups. Pacifier use reduced FLACC score (not statistically significant), crying times (statistically significant) but not heart rate. Subgroup analysis revealed a mean crying time difference of 76.52 seconds (p < 0.0171) (0-1 month) and 123.9 seconds (p < 0.0029) (1-3 month). For subgroup age > 3 months pacifier did not have any significant effect on crying time. Age adjusted regression analysis revealed that both sucrose and pacifier had significant effects on crying time. Crying time increased with both increasing age and increasing gestational age.
                Pacifiers are inexpensive, effective analgesics and are easy to use in the PED for venipuncture in infants aged 0-3 months. The benefits of sucrose alone as an analgesic require further investigation in the older infant, but sucrose does appear to provide additional benefit when used with a pacifier in this age group.
                Current Controlled Trials ISRCTN15819627.
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.