Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 2:07 AM
Study NCT ID:
NCT03981133
Status:
UNKNOWN
Last Update Posted:
2019-06-10
First Post:
2019-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration
Sponsor:
Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
Organization:
Study Overview
Official Title:
The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: