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Study Information

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 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

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

Variable Information
Total Variables: 63
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_zipWhat is your zip code?
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_lung_diseaseChronic lung disease
nih_immunosuppressive_conditionImmunosuppressive condition
nih_sickle_cell_diseaseSickle cell disease
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_conjunctivitisConjunctivitis
nih_weightWhat is your weight in pounds?
abdominal_painAbdominal pain
ageWhat is your age? (Age in years. For babies less than 1 year old, write 0 as the age)
cancerCancer
cardiovascular_diseaseCardiovascular disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
diarrheaDiarrhea
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
immunosuppressive_conditioImmunosuppressive condition
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
raceWhat is your race? Mark one or more boxes.
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
sickle_cell_diseaseSickle cell disease
skin_rashSkin rash
weight_lbsWhat is your weight? (Weight in pounds)
zipZip or Postal Code: (De-Identified zip code)
any_documented_past_medical_history-
cardiac_history-
cerebral_palsy-
covid_contacts-
Inflammatory_bowel_disease-
joint_pain-
mucus_membrane_changes-
mucus_membrane_changes_desc-
others_in_contact_family-
recent_ed_visit-
record_id-
respiratory_symptoms-
rhinorrhea_congestion-
rr_initial-
study_id-
tmax-
wheezing-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002603_Protocol_12DEC2023.pdf822.11 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_023_594-01_prevailapril15_DATA_origcopy.csvTabular Data - Non-harmonizedcsv101
rad_023_594-01_prevailapril15_DATA_transformcopy.csvTabular Data - Harmonizedcsv101