Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration
- Conditions
- Lactation
- Interventions
- Behavioral: no pacifierBehavioral: offer a pacifier
- Registration Number
- NCT03981133
- Lead Sponsor
- Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1010
Not provided
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description restricted pacifierr no pacifier recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live A: unrestricted pacifier offer a pacifier recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life
- Primary Outcome Measures
Name Time Method Prevalence of exclusive breastfeeding up to 24 weeks 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
- Secondary Outcome Measures
Name Time Method infant feeding - breastfeeding duration up to 24 weeks to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups
Trial Locations
- Locations (6)
Sanatorio de la Trinidad
🇦🇷Caba, Buenos Aires, Argentina
Hospital Privado de del Sur
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Hospital Italiano de buenos Aires
🇦🇷Caba, Buenos Aires, Argentina
Alejandro Jenik
🇦🇷Olivos, Buenos Aires, Argentina
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