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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: |
NCT01333982 |
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Date of registration:
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12/10/2010 |
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Primary sponsor: |
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Public title:
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Neonatal Sepsis, Evaluation, Bangladesh
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Scientific title:
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Evaluation of a on Community-Based Management of Neonatal Sepsis |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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20000 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01333982 |
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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: Single Blind (Subject), Primary Purpose: Health Services Research
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Shams El Arifee, MBBS, PhD |
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Address:
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Telephone:
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88620523-32 |
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Email:
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shams@icddrb.org |
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Affiliation:
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Name:
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Shams El Arifeen, MBBS, PhD |
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Address:
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Telephone:
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8860523-32 |
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Email:
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shams@icddrb.org |
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Affiliation:
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Name:
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Shams El Arifeen, MBBS, DrPh |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- development of danger signs of neonatal sepsis during neonatal period
Exclusion Criteria:
- developing signs not in neonatal period
Age minimum:
N/A
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Other: Amoxycillin, Gentamicin
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Other: Counselling
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Primary Outcome(s)
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Appropriate management of all cases of neonatal sepsis in the community by community level health care provider
[Time Frame: 18 months]
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Secondary Outcome(s)
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Newborns first bathed at least three days after birth
[Time Frame: 18 months]
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Newborns receiving breast feeding within one hour after birth
[Time Frame: 18 months]
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Newborns will be dried and wrapped immediately after birth
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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