Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal

Status: Unknown

Conditions: Lactation

Treatments: Behavioral: no pacifier; Behavioral: offer a pacifier

Study type: Interventional

Funder types: Other

Identifiers

NCT03981133

marita909

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 1,010 estimated patients

Sex: All

Ages: 6 hours to 3 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,010 participants in 2 patient groups

A: unrestricted pacifier

Experimental group

Description:

recommendation to offer a pacifier at the facility providing maternity and newborn services the first days of life

Treatment:

Behavioral: offer a pacifier

restricted pacifierr

Active Comparator group

Description:

recommendation not to offer a pacifier to normal new born infant at the maternity thre first days of live

Treatment:

Behavioral: no pacifier