NCT03981133

Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,010 (estimated)
• Sponsor: Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal · Academic / Other
• Sex: All
• Age: 6 Hours – 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Lactation

Interventions

Type	Name	Description
BEHAVIORAL	offer a pacifier	offer a pacifier to normal newborn infants the first days of life
BEHAVIORAL	no pacifier	not to offer a pacifier at 15 days of life

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-06-10
• Last updated: 2019-06-10

Locations

6 sites across 1 country: Argentina