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Omphalitis Community Based Algorithm Validation Study (OCAVS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Boston University
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Thrasher Research Fund
Information provided by (Responsible Party):
Julie M Herlihy, Boston University
ClinicalTrials.gov Identifier:
NCT01687621
First received: September 7, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Omphalitis
Procedure: Diagnostic Algorithm for Community Based Worker for Omphalitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omphalitis Community Based Algorithm Validation Study

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Validity of the omphalitis algorithm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 3257
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neonates, 1 to 10 days old
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.
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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687621

Contacts
Contact: Arthur Mazimba, MPH +260 097 8771 030 arthur.mazimba@gmail.com
Contact: Julie M Herlihy, MD, MPH 617 414 1455 herlihyj@bu.edu

Locations
Zambia
Hospitals & Community Health Centers Recruiting
Livingstone, Southern Province, Zambia
Principal Investigator: Julie M Herlihy, MD MPH         
Sponsors and Collaborators
Boston University
Bill and Melinda Gates Foundation
Thrasher Research Fund
Investigators
Principal Investigator: Julie M Herlihy, MD MPH Boston University
  More Information

Additional Information:
No publications provided

Responsible Party: Julie M Herlihy, Assistant Professor, Boston University
ClinicalTrials.gov Identifier: NCT01687621     History of Changes
Other Study ID Numbers: OCAVS
Study First Received: September 7, 2012
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee

Keywords provided by Boston University:
Omphalitis
Neonate
Zambia
Neonatal mortality
Umbilical cord infection

ClinicalTrials.gov processed this record on November 24, 2014