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Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study

Oruganti, Sivakumar, Rodrigues, Patrícia R. S., White, Daniel, Watkins, William ORCID:, Shapey, Selyf, Barrow, Anna, al Samsam, Rim, Ali, Sara, Gajraj, Malcolm, Skone, Richard, Jardine, Michelle, Evans, Jennifer, Struik, Siske, Song, Jong Eun, Abood, Lloyd, Paquete, Barbara, Foulkes, Sian, Saunders, Benjamin, Strang, Angela, Kotecha, Sarah Joanne, Phillips, Bethan, Evans, Awen, Buchanan, Iona, Bowes, Susan, Ali, Begum, Gore, Maya, Thomas-Turner, Rhian, Andrews, Robert, Zaher, Summia, Sharma, Simran, Chakraborty, Mallinath, Parkinson, Edward ORCID:, Liberatore, Federico ORCID:, Woolley, Thomas ORCID:, Edkins, Sarah ORCID:, Davies, Luke C., Moet, Linda, McLaren, James E. ORCID:, Watson, Gareth L., O'Donnell, Valerie ORCID:, Hood, Kerry ORCID: and Ghazal, Peter ORCID: 2023. Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study. BMJ Open 13 , e067002. 10.1136/bmjopen-2022-067002

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Introduction: Early recognition and appropriate management of paediatric sepsis are known to improve outcomes. A previous system’s biology investigation of the systemic immune response in neonates to sepsis identified immune and metabolic markers that showed high accuracy for detecting bacterial infection. Further gene expression markers have also been reported previously in the paediatric age group for discriminating sepsis from control cases. More recently, specific gene signatures were identified to discriminate between COVID-19 and its associated inflammatory sequelae. Through the current prospective cohort study, we aim to evaluate immune and metabolic blood markers which discriminate between sepses (including COVID-19) from other acute illnesses in critically unwell children and young persons, up to 18 years of age. Methods and analysis: We describe a prospective cohort study for comparing the immune and metabolic whole-blood markers in patients with sepsis, COVID-19 and other illnesses. Clinical phenotyping and blood culture test results will provide a reference standard to evaluate the performance of blood markers from the research sample analysis. Serial sampling of whole blood (50 μL each) will be collected from children admitted to intensive care and with an acute illness to follow time dependent changes in biomarkers. An integrated lipidomics and RNASeq transcriptomics analyses will be conducted to evaluate immune-metabolic networks that discriminate sepsis and COVID-19 from other acute illnesses. This study received approval for deferred consent. Ethics and dissemination: The study has received research ethics committee approval from the Yorkshire and Humber Leeds West Research Ethics Committee 2 (reference 20/YH/0214; IRAS reference 250612). Submission of study results for publication will involve making available all anonymised primary and processed data on public repository sites. Trial registration number: NCT04904523.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Advanced Research Computing @ Cardiff (ARCCA)
Computer Science & Informatics
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Date of First Compliant Deposit: 30 March 2023
Date of Acceptance: 14 March 2023
Last Modified: 20 Jul 2024 01:11

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