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