Influence of Pacifiers on Breastfeeding Duration
Condition: Sudden Infant Death
MeSH terms: Infant Death; Sudden Infant Death
Study type: Interventional
Phase: Phase 3

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 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:

        1. No pacifier,

        2. Pacifier introduced at 15 days.

      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.
    

Intervention name(s): offer a pacifier
Intervention type(s): Behavioral
Intervention description(s): To offer a pacifier to normal newborn infants at 15 days of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Infant; Newborn; pacifier; dummies; breastfeeding; Sudden Infant Death; SIDS; Pacifiers