NCT00306956

Brief Summary

The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,021

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

1.4 years

First QC Date

March 23, 2006

Last Update Submit

September 18, 2008

Conditions

Sudden Infant Death

Keywords

InfantNewbornpacifierdummiesbreastfeedingSudden Infant DeathSIDSPacifiers

Outcome Measures

Primary Outcomes (1)

  • The prevalence of exclusive breastfeeding for three month old infants between groups randomised to pacifier and no pacifier exposure. Pacifier introduction is delayed until 15 days to ensure that breastfeeding is firmly established.

    Three months

Secondary Outcomes (4)

  • To evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding

    one year

  • To evaluate the median breastfeeding duration in months in relation to the frequency of pacifier use

    one year

  • To test whether pacifier use is causally related with muguet, otitis and sore nipples

    one year

  • Compliance with group assignment

    one year

Study Arms (2)

A

EXPERIMENTAL

Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding

Behavioral: offer a pacifier

B

ACTIVE COMPARATOR

Recommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age

Behavioral: offer a pacifier

Interventions

offer a pacifierBEHAVIORAL

To offer a pacifier to normal newborn infants at 15 days of age

AB

Eligibility Criteria

Age14 Days - 18 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The following patients will be invited to participate before hospital discharge:
  • Women who agree not to introduce the pacifier before 2 weeks
  • Intention to exclusively breastfeed their infants for at least 3 months
  • Breastfeeding exclusively at discharge
  • Delivered a healthy singleton newborn
  • completed weeks and at least a 2.5 kg birth weight
  • Possibility of contact by telephone
  • Patients will be randomized at age 15 days if:
  • They are exclusively breastfeeding
  • They have no existing breastfeeding problems
  • Babies use no pacifiers.
  • Breastfeeding is well established
  • No maternal risk factors for lactation problems

You may not qualify if:

  • Extremely or persistently sore nipples
  • Presence of mastitis or abscess formation.
  • Medical situations contraindicating breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Privado del Sur

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Hospital Diego Paroissien

Isidro Casanova, Buenos Aires, 1765, Argentina

Location

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

San Isidro, Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, 1181ACH, Argentina

Location

Sanatorio de la Trinidad

Buenos Aires, 1425, Argentina

Location

MeSH Terms

Conditions

Sudden Infant DeathBreast Feeding

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant DeathFeeding BehaviorBehavior

Study Officials

  • Alejandro Jenik, M.D.

    Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2007

Study Completion

May 1, 2008

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

AR(5)