Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lactation

Intervention / Treatment
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* Behavioral: offer a pacifier
* Behavioral: no pacifier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: unrestricted pacifier<br>recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life | Behavioral: offer a pacifier<br>* offer a pacifier to normal newborn infants the first days of life<br>|
| Active Comparator: restricted pacifierr<br>recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live | Behavioral: no pacifier<br>* not to offer a pacifier at 15 days of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant feeding - breastfeeding duration | to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacifier, breastfeeding, sudden unexpected infant death