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
  Purpose

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.


Condition Intervention Phase
Sudden Infant Death
Behavioral: offer a pacifier
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fundacion para la Salud Materno Infantil:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1021
Study Start Date: March 2006
Study Completion Date: May 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding
Behavioral: offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
Active Comparator: B
Recommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age
Behavioral: offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age

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.

  Eligibility

Ages Eligible for Study:   up to 18 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306956

Locations
Argentina
Hospital Privado del Sur
Bahia Blanca, Buenos Aires, Argentina, 8000
Hospital Diego Paroissien
Isidro Casanova, Buenos Aires, Argentina, 1765
Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"
San Isidro, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1181ACH
Sanatorio de la Trinidad
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
Fundacion para la Salud Materno Infantil
International Childrens Medical Research Association, Switzerland.
Investigators
Principal Investigator: Alejandro Jenik, M.D. Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
  More Information

No publications provided

Responsible Party: Alejandro Jenik, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT00306956     History of Changes
Other Study ID Numbers: FUNDASAMIN101
Study First Received: March 23, 2006
Last Updated: September 18, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Fundacion para la Salud Materno Infantil:
Infant
Newborn
pacifier
dummies
breastfeeding
Sudden Infant Death
SIDS
Pacifiers

Additional relevant MeSH terms:
Death
Sudden Infant Death
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on July 22, 2014