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| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2006 | ||||
| Last Updated Date | September 18, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Time Frame: Three months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
the prevalence of exclusive breastfeeding for three months 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. | ||||
| Change History | Complete list of historical versions of study NCT00306956 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Pacifiers on Breastfeeding Duration | ||||
| Official Title ICMJE | Influence of Pacifiers on Breastfeeding Duration: a Multicentre, Randomised Controlled Trial | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Sudden Infant Death | ||||
| Intervention ICMJE | Behavioral: offer a pacifier | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1021 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: The following patients will be invited to participate before hospital discharge:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Argentina | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00306956 | ||||
| Responsible Party | Alejandro Jenik, Hospital Italiano de Buenos Aires | ||||
| Study ID Numbers ICMJE | FUNDASAMIN101 | ||||
| Study Sponsor ICMJE | Fundacion para la Salud Materno Infantil | ||||
| Collaborators ICMJE | International Childrens Medical Research Association, Switzerland. | ||||
| Investigators ICMJE |
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| Information Provided By | Fundacion para la Salud Materno Infantil | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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