Influence of Pacifiers on Breastfeeding Duration

September 18, 2008 updated by: Fundacion para la Salud Materno Infantil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1021

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, 1425
        • Sanatorio de la Trinidad
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, 8000
        • Hospital Privado del Sur
      • Isidro Casanova, Buenos Aires, Argentina, 1765
        • Hospital Diego Paroissien
      • San Isidro, Buenos Aires, Argentina
        • Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year
To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use
Time Frame: one year
one year
To test whether pacifier use is causally related with muguet, otitis and sore nipples
Time Frame: one year
one year
Compliance with group assignment
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Salud Materno Infantil

Collaborators

International Childrens Medical Research Association, Switzerland.

Investigators

  • Principal Investigator: Alejandro Jenik, M.D., Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUNDASAMIN101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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