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Influence of Pacifiers on Breastfeeding Duration

This study has been completed.
Sponsor:
Collaborator:
International Childrens Medical Research Association, Switzerland.
Information provided by:
Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier:
NCT00306956
First received: March 23, 2006
Last updated: September 18, 2008
Last verified: September 2008

March 23, 2006
September 18, 2008
March 2006
August 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
the prevalence of exclusive breastfeeding for three months 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.
Complete list of historical versions of study NCT00306956 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To test whether pacifier use is causally related with muguet, otitis and sore nipples [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Compliance with group assignment [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Influence of Pacifiers on Breastfeeding Duration
Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Sudden Infant Death
Behavioral: offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
  • Experimental: A
    Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding
    Intervention: Behavioral: offer a pacifier
  • Active Comparator: B
    Recommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age
    Intervention: Behavioral: offer a pacifier
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1021
May 2008
August 2007   (final data collection date for primary outcome measure)

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:

    • They are exclusively breastfeeding
    • They have no existing breastfeeding problems
    • Babies use no pacifiers.
    • Breastfeeding is well established
    • No maternal risk factors for lactation problems

Exclusion Criteria:

  • Extremely or persistently sore nipples
  • Presence of mastitis or abscess formation.
  • Medical situations contraindicating breastfeeding
Both
up to 18 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00306956
FUNDASAMIN101
Yes
Alejandro Jenik, Hospital Italiano de Buenos Aires
Fundacion para la Salud Materno Infantil
International Childrens Medical Research Association, Switzerland.
Principal Investigator: Alejandro Jenik, M.D. Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
Fundacion para la Salud Materno Infantil
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP