Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1021 participants
INTERVENTIONAL
2006-03-31
2008-05-31
Brief Summary
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Detailed Description
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In accordance with WHO/UNICEF recommendations, lactation consultants and other health professionals within "Baby-Friendly" institutions typically discourage the use of pacifiers in breastfed infants. The recent American Academy of Pediatrics policy statement, however, recommends pacifier use, during periods of sleep as a potential method to reduce the risk of SIDS. Previous observational studies had been unanimous in reporting an approximate doubling of the risk of early weaning with daily pacifier use. However, randomized controlled trials in developed countries, have not shown that giving pacifiers results in shorter breastfeeding duration, except when pacifiers are given in the first 5 days. It has therefore been seen that practically every author of a major study on the association between breastfeeding and pacifier use has proposed that the question can only be fully and completely answered by randomized studies. To date there are no large randomized studies evaluating the influence of pacifier use on breastfeeding duration.
Our Primary outcome is to compare the prevalence of exclusive breastfeeding at three months in infants between groups randomised to pacifier and no pacifier exposure once breastfeedings have been fully established.
Second outcome: to evaluate the effects of the pacifier's introduction when breastfeeding is firmly established at 15 days on the duration of breastfeeding.
Recruitment to the trial will take place in several public and private hospitals.
Those mothers who do not show a strong preference in regards to the introduction of the pacifier, will be randomised during the postpartum visit at 2 weeks (if well established breastfeeding is present) on two arms:
1. No pacifier,
2. Pacifier introduced at 15 days.
Structured telephone interviews will be conducted at 1, 2, 3, 4, 5, and 6 months and every 60 days thereafter until the breastfeeding has ended to record breastfeeding duration and type (exclusive or not) and pacifier use.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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A
Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding
offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
B
Recommendation not to offer a pacifier to normal newborn infant with successful breastfeeding at 15 days of age
offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
Interventions
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offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
Eligibility Criteria
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Inclusion Criteria
* 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
* 37 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
Exclusion Criteria
* Presence of mastitis or abscess formation.
* Medical situations contraindicating breastfeeding
14 Days
18 Days
ALL
Yes
Sponsors
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International Childrens Medical Research Association, Switzerland.
UNKNOWN
Fundacion para la Salud Materno Infantil
OTHER
Responsible Party
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Hospital Italiano de Buenos Aires
Principal Investigators
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Alejandro Jenik, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires
Locations
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Hospital Privado del Sur
Bahía Blanca, Buenos Aires, Argentina
Hospital Diego Paroissien
Isidro Casanova, Buenos Aires, Argentina
Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio"
San Isidro, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Sanatorio de la Trinidad
Buenos Aires, , Argentina
Countries
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Other Identifiers
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FUNDASAMIN101
Identifier Type: -
Identifier Source: org_study_id