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ClinicalTrials.gov ID

NCT03981133

Lead Sponsor

Fundación para el Estudio y Prevención de la Muerte Infantil y PerinatalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,010Estimated

Last Update Posted

Jun 10, 2019Actual

Start Date

Jan 2020Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

Official Title

The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial

Brief Summary

We will enroll 1010 mother-infant dyads in a randomized trial exploring the effect of distribution of the pacifier during the first days of life on breastfeeding prevalence and duration. .

Detailed Description

Given the scarcity of scientifically rigorous studies that address the impact of unrestricted pacifier exposure on breastfeeding we plan to conduct a multicenter, randomized, single blind, active control, parallel assignment, efficacy study to assess the impact of offering a pacifier on breastfeeding during the first days of life our hypothesis is that the introduction of a pacifier during the first days of life does not interfere with lactation

A research assistant will approach all eligible mothers during the first 6 hours after birth and will invite them to be randomized to one of the two groups:

Unrestricted pacifier ( the pacifiers can be offered liberally to infants to suck on during their stay at the facility providing maternity and newborn services) and Restricted pacifier group: ( avoid pacifier use until breastfeeding is well established) Women will be followed up at 1, 3, 4, ,6, 8, and 12 months after birth or until breastfeeding ended by a research assistant blinded to the group assignment. Interviews will be conducted by telephone using structured questionnaires designed to assess breastfeeding (exclusive or partial) prevalence and duration, and whether or not the baby had rejected a pacifier the night before the telephone interview. Rates of exclusive, partial, and any other occasional random breastfeeding will be tracked at all these time points.

• Lactation

• offer a pacifier
• no pacifier

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria

• Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
• Expressed an intention to breast feed exclusively their infant for at least 3 -months
• Possibility of contact by telephone
• Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
• Primiparous single birth
• Mother´s age 18 years or more

Exclusion Criteria:

• Maternal risk factors for lactation

  • Lack of noticeable breast enlargement during pregnancy
  • Flat or inverted nipples
  • Variation in breast appearance (marked asymmetry, hypoplastic, tubular)
  • Any previous breast surgery, including plastics procedure

• Psychosocial problems (eg, depression, poor or negative support of breastfeeding

• Mother with a chronic condition that could influence development , including feeding ability

• Mother with eating or mental disorder.

• Mothers who smoke during pregnancy

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Fundación para el Estudio y Prevención de la Muerte Infantil y PerinatalOTHER

Collaborators

Hospital Italiano de Buenos AiresOTHER

Fundacion para la Salud Materno InfantilOTHER

alejandro.jenik@hiba.org.ar5491144061380