Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03981133
• Other study ID #: marita909
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2019
• Source: Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
• Contact: Alejandro G Jenik
• Phone: 5491144061380
• Email: alejandro.jenik[@]hiba.org.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1010
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Intervention

Behavioral:
• offer a pacifier
offer a pacifier to normal newborn infants the first days of life
• no pacifier
not to offer a pacifier at 15 days of life

Locations

Country	Name	City	State
Argentina	Hospital Privado de del Sur	Bahia Blanca	Buenos Aires
Argentina	Hospital Italiano de buenos Aires	Caba	Buenos Aires
Argentina	Sanatorio de la Trinidad	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

Sponsors (3)

Lead Sponsor	Collaborator
Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal	Fundacion para la Salud Materno Infantil, Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	infant feeding - breastfeeding duration	to evaluate the duration of exclusive and any breastfeeding duration in months between the two groups	up to 24 weeks