Omphalitis Community Based Algorithm Validation Study

Omphalitis Clinical Trial

— OCAVS  

Official title:

Omphalitis Community Based Algorithm Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687621
• Other study ID #: OCAVS
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: July 20, 2015
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2015
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Omphalitis

Intervention

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.

Locations

Country	Name	City	State
Zambia	Hospitals & Community Health Centers	Livingstone	Southern Province

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Bill and Melinda Gates Foundation, Thrasher Research Fund

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the omphalitis algorithm	The primary outcome of the study is a measure of validity (concordance) of the the omphalitis algorithm generated by inter-observer kappa statistics to evaluate diagnostic concordance between the field monitors and the gold standard cord health expert on specific algorithmic questions. Questions that demonstrate high concordance will be selected for inclusion in the final algorithm. Sensitivity and specificity of the final algorithm will be generated.	10 months	No

External Links

•   Zambia Chlorhexidine Application Trial