Clinical trial NCT03981133: Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration
Official title: The Missing Answer: When is it Safe to Introduce the Pacifier to the Breastfed Baby? A Multicenter, Randomized, Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation
Keywords: pacifier
breastfeeding
sudden unexpected infant death
Lead sponsor: Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
Sponsor class: OTHER
Collaborators: name: Hospital Italiano de Buenos Aires
name: Fundacion para la Salud Materno Infantil
First posted: 2019-06-10
Enrollment: 1010
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria

* Understands the benefits and risk for offer liberally the pacifier during their stay at the maternity.
* Expressed an intention to breast feed exclusively their infant for at least 3 -months
* Possibility of contact by telephone
* Has the decision to offer a pacifier to the newborn infant , but not definite opinion about when are going to offer a pacifier
* Primiparous single birth
* Mother´s age 18 years or more

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of exclusive breastfeeding
timeFrame: up to 24 weeks
Secondary outcomes:
measure: infant feeding - breastfeeding duration
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Hospital Privado de del Sur
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Italiano de buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: Sanatorio de la Trinidad
state: Buenos Aires
city: Olivos
country: Argentina
facility: Alejandro Jenik
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t
state: Buenos Aires
city: SAn Justo
country: Argentina
facility: Centro Agustin Rocca HIBA
state: Buenos Aires
Study officials:
affiliation: Fundacion para el Estudio y la Prevencion de la Muerte Infantil y Perinatal
name: alejandro G Jenik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal
name: Aleajndro G Jenik, MD
role: PRINCIPAL_INVESTIGATOR
References: