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The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.
Full description
The incidence of Sudden infant death syndrome in developing countries is comparable with that of developed countries. Two important risk factors with implications for prevention are prone sleeping position and the association with smoke. Also, breastfeeding has been reported to be protective against SIDS.
In accordance with WHO/UNICEF recommendations, lactation consultants and other health professionals within "Baby-Friendly" institutions typically discourage the use of pacifiers in breastfed infants. The recent American Academy of Pediatrics policy statement, however, recommends pacifier use, during periods of sleep as a potential method to reduce the risk of SIDS. Previous observational studies had been unanimous in reporting an approximate doubling of the risk of early weaning with daily pacifier use. However, randomized controlled trials in developed countries, have not shown that giving pacifiers results in shorter breastfeeding duration, except when pacifiers are given in the first 5 days. It has therefore been seen that practically every author of a major study on the association between breastfeeding and pacifier use has proposed that the question can only be fully and completely answered by randomized studies. To date there are no large randomized studies evaluating the influence of pacifier use on breastfeeding duration.
Our Primary outcome is to compare the prevalence of exclusive breastfeeding at three months in infants between groups randomised to pacifier and no pacifier exposure once breastfeedings have been fully established.
Second outcome: to evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding.
Recruitment to the trial will take place in several public and private hospitals.
Those mothers who do not show a strong preference in regards to the introduction of the pacifier, will be randomised during the postpartum visit at 2 weeks (if well established breastfeeding is present) on two arms:
Structured telephone interviews will be conducted at 1, 2, 3, 4, 5, and 6 months and every 60 days thereafter until the breastfeeding has ended to record breastfeeding duration and type (exclusive or not) and pacifier use.
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Inclusion criteria
The following patients will be invited to participate before hospital discharge:
Women who agree not to introduce the pacifier before 2 weeks
Intention to exclusively breastfeed their infants for at least 3 months
Breastfeeding exclusively at discharge
Delivered a healthy singleton newborn
37 completed weeks and at least a 2.5 kg birth weight
Possibility of contact by telephone
Patients will be randomized at age 15 days if:
Exclusion criteria
1,021 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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