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| Sponsors and Collaborators: |
Fundacion para la Salud Materno Infantil International Childrens Medical Research Association, Switzerland. |
|---|---|
| Information provided by: | Fundacion para la Salud Materno Infantil |
| ClinicalTrials.gov Identifier: | NCT00306956 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sudden Infant Death |
Behavioral: offer a pacifier |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial |
| Enrollment: | 1021 |
| Study Start Date: | March 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Recommendation to offer a pacifier to 15 days old newborn infants with successful breastfeeding
|
Behavioral: offer a pacifier
To offer a pacifier to normal newborn infants at 15 days of age
|
|
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
To offer a pacifier to normal newborn infants at 15 days of age
|
The incidence of Sudden infant death syndrome in developing countries is comparable with that of developed countries. Two important risk factors with implications for prevention are prone sleeping position and the association with smoke. Also, breastfeeding has been reported to be protective against SIDS. 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:
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.
Eligibility| Ages Eligible for Study: | up to 18 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The following patients will be invited to participate before hospital discharge:
Patients will be randomized at age 15 days if:
Exclusion Criteria:
Contacts and Locations| Argentina | |
| Hospital Italiano de Buenos Aires | |
| Buenos Aires, Argentina, 1181ACH | |
| Sanatorio de la Trinidad | |
| Buenos Aires, Argentina, 1425 | |
| Argentina, Buenos Aires | |
| Hospital Diego Paroissien | |
| Isidro Casanova, Buenos Aires, Argentina, 1765 | |
| Hospital Privado del Sur | |
| Bahia Blanca, Buenos Aires, Argentina, 8000 | |
| Hospital Municipal Materno Infantil de San Isidro "Dr. Carlos Gianantonio" | |
| San Isidro, Buenos Aires, Argentina | |
| Principal Investigator: | Alejandro Jenik, M.D. | Jefe de Recién Nacido Normal, Hospital Italiano, Buenos Aires |
More Information
| Responsible Party: | Hospital Italiano de Buenos Aires ( Alejandro Jenik ) |
| Study ID Numbers: | FUNDASAMIN101 |
| Study First Received: | March 23, 2006 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00306956 History of Changes |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
Infant Newborn pacifier dummies |
breastfeeding Sudden Infant Death SIDS Pacifiers |
|
Sudden Infant Death Syndrome Sudden Infant Death Death Death, Sudden |
|
Death Sudden Infant Death Pathologic Processes Death, Sudden |