NCT03981133

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. .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,010

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

2.9 years

First QC Date

June 6, 2019

Last Update Submit

June 7, 2019

Conditions

Lactation

Keywords

pacifierbreastfeedingsudden unexpected infant death

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • infant feeding - breastfeeding duration

    up to 24 weeks

Study Arms (2)

A: unrestricted pacifier

EXPERIMENTAL

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

Behavioral: offer a pacifier

restricted pacifierr

ACTIVE COMPARATOR

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

Behavioral: no pacifier

Interventions

offer a pacifierBEHAVIORAL

offer a pacifier to normal newborn infants the first days of life

A: unrestricted pacifier
no pacifierBEHAVIORAL

not to offer a pacifier at 15 days of life

restricted pacifierr

Eligibility Criteria

Age6 Hours - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Privado de del Sur

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Hospital Italiano de buenos Aires

CABA, Buenos Aires, 1199ABB, Argentina

Location

Sanatorio de la Trinidad

CABA, Buenos Aires, 1425, Argentina

Location

Alejandro Jenik

Olivos, Buenos Aires, 1636, Argentina

Location

Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"t

San Isidro, Buenos Aires, Argentina

Location

Centro Agustin Rocca HIBA

San Justo, Buenos Aires, B1702, Argentina

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro G Jenik

CONTACT

5491144061380alejandro.jenik@hiba.org.ar

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor consultant pediatrics

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

weight,gestational age,mother age, vaginal, cesarean,bedsharing, contact skin to skin

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
data will be available within 6 months of study
Access Criteria
data access requests will be reviewed by an external independent review panel. Requestors will be required to sifn a Data Access Agreement
More information

Locations

AR(6)