Marilyn M Benis1. 1. Department of Pediatrics, Vermont Children's Hospital, Fletcher Allen Health Care, Burlington, VT, USA. marilyn.benis@vtmednet.org
Abstract
BACKGROUND: The pacifier, a non-nutritive sucking device, is commonly used for calming infants. The World Health Organization/United Nation's Children's Fund (WHO/UNICEF) Baby Friendly Hospital Initiative recommends avoiding pacifiers in breastfed term infants because it is thought to lead to early weaning. Most studies that found early weaning to be associated with pacifier use were observational in design. This Critically Appraised Topic evaluates a randomized controlled trial that examines pacifiers and early weaning. PURPOSE: The objectives of the study analyzed were to test whether regular pacifier use has a causal effect on early weaning from the breast by 3 months of age and to assess the difference in results when the data are examined using randomized intervention allocation (intention to treat) versus observational use of pacifiers. METHODS:Two hundred eighty-one breastfeeding women and their healthy term infants were allocated randomly to 1 of 2 counseling interventions. Both groups received basic breastfeeding promotion information. In addition, the experimental group mothers (n = 140) were asked to avoid pacifiers and were given other alternatives for comforting a crying infant. Logs detailing infant crying, fussing, and pacifier use were completed at 4, 6, and 9 weeks of age, and an interview at 3 months determined the duration of breastfeeding. RESULTS: The experimental group had a higher rate of total avoidance of pacifier use (38.6% v 16% in the control group) and less daily use of pacifiers (40.8% v 55.7%). When the data were analyzed based on the intention to treat (randomized allocation), the experimental intervention group had similar rates of early weaning as the control group (18.9% v 18.3%). When the data were analyzed on the treatment given (ignoring randomization), a strong observational association was found between daily exposure to pacifiers and weaning by 3 months (25% v 12.9% of exposed versus unexposed groups). CONCLUSION: The results imply that pacifier use may be a marker of breastfeeding difficulties or decreased maternal motivation to breastfeed, as opposed to being the causal agent in early weaning.
RCT Entities:
BACKGROUND: The pacifier, a non-nutritive sucking device, is commonly used for calming infants. The World Health Organization/United Nation's Children's Fund (WHO/UNICEF) Baby Friendly Hospital Initiative recommends avoiding pacifiers in breastfed term infants because it is thought to lead to early weaning. Most studies that found early weaning to be associated with pacifier use were observational in design. This Critically Appraised Topic evaluates a randomized controlled trial that examines pacifiers and early weaning. PURPOSE: The objectives of the study analyzed were to test whether regular pacifier use has a causal effect on early weaning from the breast by 3 months of age and to assess the difference in results when the data are examined using randomized intervention allocation (intention to treat) versus observational use of pacifiers. METHODS: Two hundred eighty-one breastfeeding women and their healthy term infants were allocated randomly to 1 of 2 counseling interventions. Both groups received basic breastfeeding promotion information. In addition, the experimental group mothers (n = 140) were asked to avoid pacifiers and were given other alternatives for comforting a crying infant. Logs detailing infant crying, fussing, and pacifier use were completed at 4, 6, and 9 weeks of age, and an interview at 3 months determined the duration of breastfeeding. RESULTS: The experimental group had a higher rate of total avoidance of pacifier use (38.6% v 16% in the control group) and less daily use of pacifiers (40.8% v 55.7%). When the data were analyzed based on the intention to treat (randomized allocation), the experimental intervention group had similar rates of early weaning as the control group (18.9% v 18.3%). When the data were analyzed on the treatment given (ignoring randomization), a strong observational association was found between daily exposure to pacifiers and weaning by 3 months (25% v 12.9% of exposed versus unexposed groups). CONCLUSION: The results imply that pacifier use may be a marker of breastfeeding difficulties or decreased maternal motivation to breastfeed, as opposed to being the causal agent in early weaning.
Authors: Antonio J Ledo Alves da Cunha; Alvaro Madeiro Leite; Marcia Maria Tavares Machado Journal: Indian J Pediatr Date: 2005-03 Impact factor: 1.967