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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 November 2012 |
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Main ID: |
NCT01428232 |
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Date of registration:
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29/08/2011 |
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Primary sponsor: |
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Public title:
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Effectiveness of Well-child Clinics as the "Community" Basis of Step 10 of the Baby Friendly Hospital Initiative
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Scientific title:
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Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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992 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01428232 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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Congo
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Contacts
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Name:
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Frieda Behets, Ph.D, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Name:
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Marcel Yotebieng, M.D, MPH, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Name:
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Miriam Labbok, MD, MPH, FACPM, IBCLC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- mothers of healthy infants being discharged from participating maternities who intend
to attend well-baby clinic visits in the same health care facilities until the child
will be at least 6 months
Exclusion Criteria:
- refusal to participate, not speaking Lingala nor French, unable to breastfeed
Age minimum:
N/A
Age maximum:
3 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breastfeeding
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Intervention(s)
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Other: BFHI steps 1-9 +well-child clinic
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Other: implementation of the Baby-Friendly Hospital Initiative
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Primary Outcome(s)
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Early initiation of breastfeeding
[Time Frame: Within 1 hour of birth]
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Exclusive breastfeeding rate
[Time Frame: up to 6 months after birth]
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Secondary Outcome(s)
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Amount and type of breastfeeding support given by Health care provider to mothers
[Time Frame: in the first 6 months after birth]
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Episodes of diarrhea
[Time Frame: in the first 6 months of life]
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Episodes of Lower Respiratory Track Infection
[Time Frame: in the first 6 months of life]
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Number of hospitalization
[Time Frame: in the first 6 months of life]
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Number of mothers seeking breastfeeding help
[Time Frame: in the first 6 months of life]
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Partial Breastfeeding rate
[Time Frame: up to 6 months after birth]
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Secondary ID(s)
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09-000076-AT11-123-UNC-DRC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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