dbGaP Study Accession: phs002603
NIH Institute/Center: NICHD
RADx Data Program: RADx-rad
Release Date: 07/21/2022
DOI: 10.60773/wyqe-xw03
Study Description: The recent emergence of SARS-CoV-2 and resultant pandemic of COVID-19 disease has overwhelmed global health systems and led to over 200,000 American deaths to date. While initial reports suggested that SARS-CoV-2 infection in children was generally benign, a novel post-inflammatory syndrome known as multisystem inflammatory syndrome in children (MIS-C) has now been described. MIS-C in children is characterized by fever, systemic inflammation, and end-organ involvement, and the majority of patients are IgG seropositive for SARS-CoV-2. Because the clinical features of MIS-C overlap with other infections and inflammatory disorders, new strategies for diagnosis of MIS-C in febrile children are urgently needed. The immediate objective of this study was to determine the reproducible changes in breath, urine, and salivary volatile composition in children diagnosed with MIS-C. These discovery studies were integrated with clinical and immunological profiling to develop and validate a novel and much-needed MIS-C diagnostic, which was expected to have a major impact on care of febrile children. The long-term goal of this study was to develop a diagnostic strategy to distinguish children with MIS-C from children with other causes of fever.
Updated Date: 12/09/2022
Principal Investigator: John, Audrey
Has Data Files: Yes
Study Domain: Multisystem Inflammatory Syndrome (MIS); Multisystem Inflammatory Syndrome in Children (MIS-C); Novel Biosensing and VOC
Data Collection Method: Breath Analysis Device / Airborne Detection Device
Keywords: Immunological Profiling; MIS-C Diagnosis; Clinical Profiling
Study Design: Longitudinal Cohort
Multi-Center Study: FALSE
Data Types: Immunological; Metabolomic; Clinical; Electronic Medical Records; Other
Data Types, Other: Immunological Profiling
Study Start Date: 01/01/2021
Study End Date: 11/30/2022
Species: Human Data
Estimated Cohort Size: 150
Study Population Focus: Children
Publication URL: https://pubmed.ncbi.nlm.nih.gov/33277976/; https://pubmed.ncbi.nlm.nih.gov/33907759/; https://pubmed.ncbi.nlm.nih.gov/34365798/; https://pubmed.ncbi.nlm.nih.gov/35118829/; https://pubmed.ncbi.nlm.nih.gov/35368385/
Acknowledgement Statement: This study was supported through funding, 4R61HD105594-02, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-rad program. This work was supported by the Children’s Hospital of Philadelphia Research Institute, and AOJ is an Investigator in the Pathogenesis of Infectious Diseases (PATH) of the Burroughs Wellcome Fund. Approved users should acknowledge the provision of data access by dbGaP for accession phs002603.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
Funding Opportunity Announcement (FOA) Number: RFA-OD-20-023
NIH Grant or Contract Number(s): 4R61HD105594-02
Consent/Data Use Limitations: General Research Use