Influence of Unrestricted Introduction of Pacifiers on Breastfeeding Duration

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

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. .

Study Overview

• Status: Unknown
• Conditions: Lactation
• Intervention / Treatment: Behavioral: offer a pacifier; Behavioral: no pacifier

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1010
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, 8000
      • Hospital Privado de del Sur
    • Caba, Buenos Aires, Argentina, 1199ABB
      • Hospital Italiano de Buenos Aires
    • Caba, Buenos Aires, Argentina, 1425
      • Sanatorio de la Trinidad
    • Olivos, Buenos Aires, Argentina, 1636
      • Alejandro Jenik
    • SAn Justo, Buenos Aires, Argentina, B1702
      • Centro Agustin Rocca HIBA
    • San Isidro, Buenos Aires, Argentina
      • Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 hours to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación para el Estudio y Prevención de la Muerte Infantil y Perinatal
• Collaborators: Hospital Italiano de Buenos Aires; Fundacion para la Salud Materno Infantil
• Investigators: Principal Investigator: alejandro G Jenik, MD, Fundacion para el Estudio y la Prevencion de la Muerte Infantil y Perinatal; Principal Investigator: Aleajndro G Jenik, MD, Fundacion para erl Estudio y Prevencionde la Muerte Subita y Perinatal

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: breastfeeding; pacifier; sudden unexpected infant death
• Other Study ID Numbers: marita909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin
• IPD Sharing Time Frame: data will be available within 6 months of study
• IPD Sharing Access Criteria: data access requests will be reviewed by an external independent review panel. Requestors will be required to sifn a Data Access Agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No