Omphalitis Clinical Trial
Official title:
Omphalitis Community Based Algorithm Validation Study
The objective of this study is to develop and test a simple community-based diagnostic
algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated
community-based algorithms developed and tested in the sub-Saharan context where the
manifestations of omphalitis presentation may vary and diagnosis could be potentially more
challenging in infants with darker skin color. Given the current attention to cord care at
the global and national policy level, validated community-based algorithms will be needed to
allow primary health workers to identify cord infections and reduce associated morbidity.
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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