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: No

Study Domain: Multisystem Inflammatory Syndrome (MIS); Multisystem Inflammatory Syndrome in Children (MIS-C); Novel Biosensing or VOC

Data Collection Method: Breath Analysis or Airborne Detection Device

Keywords: Clinical Profiling; Immunological Profiling; MIS-C Diagnosis

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Electronic Medical Records; Immunological; Metabolomic

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