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.
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Oruganti Sivakumar, Rodrigues Patrícia R S, White Daniel, Watkins William John, 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, Liberatore Federico, Woolley Thomas, Edkins Sarah, Davies Luke C, Moet Linda, McLaren James E, Watson Gareth L, O'Donnell Valerie, Hood Kerry, Ghazal Peter
Аннотация
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.