The National Institutes of Health (NIH) has launched an observational study to evaluate the short- and long-term health outcomes of SARS-CoV-2 infection in children, including multisystem inflammatory syndrome in children (MIS-C), and to characterize the immunologic pathways associated with different disease presentations and outcomes, according to a press release from NIH.
The study, called the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM), will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds at approximately 20 sites nationwide. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is sponsoring and funding the study. The PRISM study is part of a research effort led by NIH's National Heart, Lung, and Blood Institute and Eunice Kennedy Shriver National Institute of Child Health and Human Development to understand MIS-C.
Although SARS-CoV-2 infection usually causes either no illness or only mild illness in children, some children become seriously ill at the time of infection, while others who initially have no symptoms later develop MIS-C. MIS-C is a life-threatening condition marked by severe inflammation of one or more parts of the body, including the heart, lungs, kidneys, brain, skin, eyes and gastrointestinal organs. The syndrome typically begins several weeks after SARS-CoV-2 exposure and disproportionately affects Black and Hispanic children.
The PRISM study aims to fill gaps in understanding of the clinical spectrum of COVID-19 in children and young adults, the long-term outcomes of SARS-CoV-2 infection in these populations, and the underlying immunologic basis of MIS-C. It is led by the department of pediatrics in Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, TN.
The PRISM study team is enrolling children and young adult volunteers with detectable SARS-CoV-2 in respiratory samples, with symptoms of MIS-C, or both. Participants will be followed for at least one year.
The study has two main goals. The first is to determine the proportion of children who die, are re-hospitalized after an initial hospital admission, or have major health complications due to SARS-CoV-2 at six and 12 months after initial presentation with COVID-19, MIS-C, or both. The second is to determine the immunologic mechanisms and characteristics associated with different forms of MIS-C and COVID-19 in children. Results are expected in mid-2022.
