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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,010
offer a pacifier to normal newborn infants the first days of life
not to offer a pacifier at 15 days of life
Hospital Privado de del Sur
Bahía Blanca, Buenos Aires, Argentina
Hospital Italiano de buenos Aires
CABA, Buenos Aires, Argentina
Sanatorio de la Trinidad
CABA, Buenos Aires, Argentina
Alejandro Jenik
Olivos, Buenos Aires, Argentina
Prevalence of exclusive breastfeeding
To compare the prevalence of exclusive breastfeeding at three, four and six months in infants between groups randomized to unrestricted pacifier group and restricted pacifier group
Time frame: up to 24 weeks
infant feeding - breastfeeding duration
to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups
Time frame: up to 24 weeks
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Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t
San Isidro, Buenos Aires, Argentina
Centro Agustin Rocca HIBA
San Justo, Buenos Aires, Argentina