Clinical Trial: Influence of Pacifiers on Breastfeeding Duration
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial
Brief Summary: 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.
Detailed Summary:
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
Sponsor: Fundacion para la Salud Materno Infantil
Current Primary Outcome: The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established. [ Time Frame: Three months ]
Original Primary Outcome: The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established.
Current Secondary Outcome:
- To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding [ Time Frame: one year ]
- To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use [ Time Frame: one year ]
- To test whether pacifier use is causally related with muguet, otitis and sore nipples [ Time Frame: one year ]
- Compliance with group assignment [ Time Frame: one year ]
Original Secondary Outcome:
- To evaluate the effects of pacifiers introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding
- To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use.
- To test whether pacifier use is causally related with muguet, otitis and sore nipples.
Information By: Fundacion para la Salud Materno Infantil
Dates:
Date Received: March 23, 2006
Date Started: March 2006
Date Completion:
Last Updated: September 18, 2008
Last Verified: September 2008
