COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)

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PROJECT SUMMARY/ABSTRACT The impact of the current COVID-19 global pandemic is likely underestimated. The specific impact on pregnant women, their infants and children is even less well characterized. We will use the infrastructure of the Duke / Vanderbilt Trial Innovation Center to address these knowledge gaps with three projects. We will use an existing electronic data warehouse of clinical data from approximately 100,000 infants admitted to over 200 neonatal intensive care units in the US to examine the epidemiology and outcomes through 12 months of age for infants born to mothers during the current pandemic. Our collaborative research team, comprising neonatologists and biostatisticians from the Duke Clinical Research Institute (DCRI) and the Pediatrix Medical Group, is uniquely positioned to complete this project. In addition, we will perform a direct-to-family observational study to evaluate the natural history of SARS-CoV-2 infection in children exposed to the virus presumably via health care worker household contact. Up to 1000 children will be enrolled across the United States. We will identify households using existing registries/trials and will evaluate the rate of infection, viral shedding, and immune response of children exposed to SARS-CoV-2. Finally, to realize the full value of the data collected as part of the multiple ongoing COVID-19 studies, data needs to be curated and harmonized. Here, data curation is defined as a metadata management activity that results in data with well-defined outcomes and exposures. The majority of curation will occur at individual study level. After the data have been harmonized, we will perform detailed quality checks. The resulting harmonized data will made availabel at different timepoints to various audiences with the final result beign a publically available de-identitified dataset. As a result of this research, we will fill major knowledge gaps related to COVID-19 and improve public health.