NCT01687621

Omphalitis Community Based Algorithm Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,009 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 1 Day – 10 Days
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Omphalitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-09-19
• Last updated: 2015-07-22

Locations

1 site across 1 country: Zambia