Omphalitis Community Based Algorithm Validation Study (OCAVS)

Boston University

Status: Completed

Conditions: Omphalitis

Treatments: Procedure: Diagnostic Algorithm for Community Based Worker for Omphalitis

Study type: Observational

Funder types: Other

Identifiers

NCT01687621

OCAVS

Details and patient eligibility

About

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.

Enrollment: 1,009 patients

Sex: All

Ages: 1 to 10 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia
• No prior diagnosis of omphalitis
• Guardian willing to allow their newborn to participate in the study
• Guardian aged 15 and above

Trial design

1,009 participants in 1 patient group

Neonates, 1 to 10 days old

Description:

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.

Treatment:

Procedure: Diagnostic Algorithm for Community Based Worker for Omphalitis