Omphalitis Community Based Algorithm Validation Study

CompletedOBSERVATIONAL
Enrollment

1,009

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Omphalitis
Interventions
PROCEDURE

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.

Trial Locations (1)

Unknown

Hospitals & Community Health Centers, Livingstone

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Thrasher Research Fund

OTHER

lead

Boston University

OTHER

NCT01687621 - Omphalitis Community Based Algorithm Validation Study | Biotech Hunter | Biotech Hunter