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 Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_zip | What is your zip code? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_vaping_yn | Vaping use (Yes or No) |
nih_nicotine_yn | Nicotine use (Yes or No) |
nih_alcohol_yn | Alcohol use (Yes or No) |
nih_asthma | Asthma |
nih_cancer | Cancer |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_chronic_lung_disease | Chronic lung disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_immunosuppressive_condition | Immunosuppressive condition |
nih_serious_mental_illness | Serious mental illness |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_conjunctivitis | Conjunctivitis |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
abdominal_pain | Abdominal pain |
age | What is your age? (Age in years. For babies less than 1 year old, write 0 as the age) |
alcohol_use | Alcohol Use |
asthma | Asthma |
cancer | Cancer |
cardiovascular_disease | Cardiovascular disease |
chills | Chills |
chronic_kidney_disease | Chronic kidney disease |
chronic_lung_disease | Chronic lung disease |
conjunctivitis | Conjunctivitis |
cough | Cough |
diabetes | Diabetes |
diarrhea | Diarrhea |
employment | Are you employed? |
ethnicity | Are you of Hispanic or Latino origin? |
excessive_fatigue | Excessive fatigue |
fever | Fever |
headache | Headache |
height_feet | Height Feet |
height_inches | Height Inches |
hypertension | Hypertension |
immunosuppressive_conditio | Immunosuppressive condition |
insurance | What kind of health insurance do you have? |
muscle_ache | Muscle ache |
nausea_vomiting | Nausea/vomiting |
new_loss_of_taste_or_smell | New loss of taste or smell |
nicotine | Nicotine Use |
pregnancy_status | Pregnancy status |
race | What is your race? Mark one or more boxes. |
serious_mental_illness | Serious mental illness |
sex | What is your biological sex assigned at birth? |
shortness_of_breath_or_dif | Shortness of breath or difficulty breathing |
sickle_cell_disease | Sickle cell disease |
skin_rash | Skin rash |
vaping | Vaping Use |
weight_lbs | What is your weight? (Weight in pounds) |
zip | Zip or Postal Code: (De-Identified zip code) |
DiagnosisClusterDSC | - |
study_id | - |