Skip to main content
This repository is under review for potential modification in compliance with Administration directives.
Study Information

dbGaP Study Accession: phs002585

NIH Institute/Center: NICHD

RADx Data Program: RADx-rad

Release Date: 07/21/2022

DOI: 10.60773/q345-4e35

Study Description: This work was directed at characterizing pediatric COVID-19 and stratifying incoming patients by projected (future) disease severity. Such stratification has several implications: immediately improving treatment planning, and as disease mechanistic pathways are uncovered, directing treatment. Predicting future severity informed the risks of outpatient treatment; to the patients themselves, their family, other caregivers/cohabitants, and to schools and employers. As varying levels of reopening are adopted across the country (and the world), such prognostication informed policy on the handling of pediatric carriers in the community. Based on preliminary analysis, it is asserted that a combination of novel assays including quantitative serology inflammatory markers (cytokine/chemokine profiles, immune profiles), transcriptomics, epigenomics, longitudinal physiological monitoring, time series analysis, imaging, radiomics and clinical observation including social determinants of health, contains adequate information even at early stages of infection to stratify the disease and predict disease severity. An artificial intelligence/machine learning approach was utilized to integrate this rich and heterogeneous dataset, characterize the spectrum of disease and identify biosignatures that predict severity in progressive disease. To facilitate translation of the approaches developed in this work to a wide user community, a Translational Development function was incorporated to oversee the design-control process and ensure readiness of the methods for regulatory review. Incorporated into the timelines are appropriate regulatory milestones intended to conform with the Emergency Use Authorization (EUA) programs in effect for SARS-CoV-2 diagnostics.

Updated Date: 01/18/2024

Principal Investigator: Annapragada, Ananth V

Has Data Files: Yes

Study Domain: Artificial Intelligence or Machine Learning; Social Determinants of Health

Data Collection Method: Real-World Data

Keywords: Data Science; Pediatric COVID-19; Timeseries Forecasting

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Electronic Medical Records

Study Start Date: 01/01/2021

Study End Date: 11/30/2022

Species: Human

Estimated Cohort Size: 7200

Study Population Focus: Children

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34022420/; https://pubmed.ncbi.nlm.nih.gov/34560062/; https://pubmed.ncbi.nlm.nih.gov/34911654/; https://pubmed.ncbi.nlm.nih.gov/34977312/; https://pubmed.ncbi.nlm.nih.gov/35439401/; https://pubmed.ncbi.nlm.nih.gov/35568731/; https://pubmed.ncbi.nlm.nih.gov/36326636/; https://pubmed.ncbi.nlm.nih.gov/37685502/

Acknowledgement Statement: This study was supported through funding, 4R61HD105593-02, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-rad program. This data was collected and awarded to the Baylor College of Medicine, PI: Annapragada. Approved users should acknowledge the provision of data access by dbGaP for accession phs002585.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): 4R61HD105593-02

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 74
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_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_vaping_ynVaping use (Yes or No)
nih_nicotine_ynNicotine use (Yes or No)
nih_alcohol_ynAlcohol use (Yes or No)
nih_asthmaAsthma
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_lung_diseaseChronic lung disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_immunosuppressive_conditionImmunosuppressive condition
nih_serious_mental_illnessSerious mental illness
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
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_heightWhat is your height in inches?
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)
alcohol_useAlcohol Use
asthmaAsthma
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
diabetesDiabetes
diarrheaDiarrhea
employmentAre you employed?
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
insuranceWhat kind of health insurance do you have?
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
pregnancy_statusPregnancy status
raceWhat is your race? Mark one or more boxes.
serious_mental_illnessSerious mental illness
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
vapingVaping Use
weight_lbsWhat is your weight? (Weight in pounds)
zipZip or Postal Code: (De-Identified zip code)
DiagnosisClusterDSC-
study_id-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002585_Initial Survey.pdf71.10 KB
Study Documentationphs002585_Protocol_14SEP2020.pdf199.76 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_593-01_bcmaicorekids_DATA_origcopy.csvTabular Data - Non-harmonizedcsv77609
rad_023_593-01_bcmaicorekids_DATA_transformcopy.csvTabular Data - Harmonizedcsv77609