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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT02386592 |
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Date of registration:
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17/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevention of Nosocomial Bacteremia Among Zambian Neonates
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Scientific title:
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Prevention of Nosocomial Bacteremia and Mortality Among Neonates at a Tertiary Referral Center in Zambia |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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9410 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02386592 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Davidson H Hamer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BU School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Neonates admitted to the study site NICU during the study period (including both
"inborn" and "outborn" neonates)
Exclusion Criteria:
- Neonates without documented birth date
- Parent or guardian unavailable or unwilling to provide consent
Age minimum:
N/A
Age maximum:
28 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neonatal Mortality
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Neonatal Sepsis
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Intervention(s)
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Other: Infection control reminders via SMS text
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Behavioral: Infection control training
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Behavioral: Hand hygiene (HH)
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Drug: Chlorhexidine gluconate (CHG)
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Primary Outcome(s)
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All-cause neonatal mortality in hospitalized neonates
[Time Frame: 18 months]
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Secondary Outcome(s)
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Prevalence of nosocomial bacteremia caused by MDR-GNR infections among hospitalized neonates
[Time Frame: 18 months]
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Incidence of nosocomial bacteremia in hospitalized neonates
[Time Frame: 18 months]
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Attributable risk of maternal, neonatal, hospital factors and nosocomial bacteremia among hospitalized neonates
[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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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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