OmphalitisOCAVSNCT01687621
Omphalitis Community Based Algorithm Validation Study
An observational study of Omphalitis, run by Boston University at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Ages 1 day to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Omphalitis
- What is being tested?
- Diagnostic Algorithm for Community Based Worker for Omphalitis
- Type of treatment
- Surgery or procedure
- How many people
- 1,009 participants
- Where
- 1 siteZambia
- Study dates
- Sep 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Hospitals & Community Health Centers
Livingstone, Southern Province
About this 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.
- Conditions
- Omphalitis
- Being tested
- Diagnostic Algorithm for Community Based Worker for Omphalitis
- Keywords
- Omphalitis, Neonate, Zambia, Neonatal mortality, Umbilical cord infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Algorithm for Community Based Worker for OmphalitisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Diagnostic Algorithm for Community Based Worker for Omphalitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OmphalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Thrasher Research Fund
- Responsible party
- Principal investigator, Julie M Herlihy, Boston University
- Investigators
- Julie M Herlihy, MD MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687621
- Sponsor's protocol ID
- OCAVS
- Acronym
- OCAVS
- Status last verified
- Jul 2015
- First submitted
- 7 Sep 2012
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omphalitis Community Based Algorithm Validation Study
- ClinicalTrials.gov ID
- NCT01687621
- Acronym / sponsor ID
- OCAVS / OCAVS
- Conditions
- Omphalitis
- Keywords
- Omphalitis, Neonate, Zambia, Neonatal mortality, Umbilical cord infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Thrasher Research Fund
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates, 1 to 10 days old | – | Procedure: Diagnostic Algorithm for Community Based Worker for OmphalitisNeonates 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. |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Algorithm for Community Based Worker for OmphalitisAfter 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. | Procedure or surgery | Neonates, 1 to 10 days old |
Primary outcome
Validity of the omphalitis algorithm
Time frame: 10 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Zambia Chlorhexidine Application TrialLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M Herlihy, MD MPH principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Omphalitis, run by Boston University at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the omphalitis algorithm (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.