Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1009 participants
OBSERVATIONAL
2012-09-30
2013-07-31
Brief Summary
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After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits will undergo two independent, parallel evaluations; first, by a community level worker and second, by a Zambian medical doctor (gold standard). A third independent assessment of a photo of the cord will be performed remotely by a board-certified pediatrician. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neonates, 1 to 10 days old
Neonates between day 1-10 of life presenting to hospitals and community health centers in Southern Province, Zambia, with no prior diagnosis of omphalitis, whose guardian, aged 15 and above, is willing to allow their newborn to participate in the study.
Diagnostic Algorithm for Community Based Worker for Omphalitis
After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
Interventions
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Diagnostic Algorithm for Community Based Worker for Omphalitis
After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
Eligibility Criteria
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Inclusion Criteria
* No prior diagnosis of omphalitis
* Guardian willing to allow their newborn to participate in the study
* Guardian aged 15 and above
1 Day
10 Days
ALL
Yes
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Thrasher Research Fund
OTHER
Boston University
OTHER
Responsible Party
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Julie M Herlihy
Assistant Professor
Principal Investigators
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Julie M Herlihy, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Hospitals & Community Health Centers
Livingstone, Southern Province, Zambia
Countries
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Related Links
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Zambia Chlorhexidine Application Trial
Other Identifiers
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OCAVS
Identifier Type: -
Identifier Source: org_study_id
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