Omphalitis Community Based Algorithm Validation Study (OCAVS)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Southern Province
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Livingstone, Southern Province, Zambie
- Hospitals & Community Health Centers
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Validity of the omphalitis algorithm
Časové okno: 10 months
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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.
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10 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Julie M Herlihy, MD MPH, Boston University
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- OCAVS
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