Carelon Research coordinating first US longitudinal study to understand new COVID-19 pediatric syndrome with greater impact on Black and Latino children

Carelon Research, an outcomes research company of Elevance Health, is managing a new study to help understand and combat the pediatric public health emergency arising from the COVID-19 pandemic.

Wilmington, DE – November 16, 2020 – The study, launched in September, has been named the MUSIC study, short for the long-term outcomes after the Multisystem Inflammatory Syndrome In Children. It will be the first study to provide long-term outcome data on the newly defined multisystem inflammatory syndrome in children, or MIS-C, which usually occurs in otherwise healthy children and has disproportionately affected Black and Hispanic/Latino children.

“This study could provide pediatricians and others with timely information to help them identify and react to children with MIS-C symptoms,” said Julie Miller, staff vice president of clinical research and principal investigator of the Pediatric Heart Network at Carelon Research, the coordinating center for MUSIC.

The study is actively enrolling a broad range of participants, as part of Elevance Health and Carelon Research’s commitment to combat the global pandemic, address health inequities and meet the evolving needs of Carelon Research members and the broader community.

The study will include about 600 children from all over the country and Canada and will capture data from children who have already been diagnosed and recovered, as well as those who become infected within the coming 24 months.

Initially, COVID-19 appeared to be significantly less frequent in the young, leading to the belief that children were largely spared from the disease. However, reports of children with a rare condition associated with COVID-19, now known as MIS-C, first appeared from England in April 2020, and identification of cases in the US followed quickly thereafter.

MIS-C, as identified in those diagnosed with SARS-CoV-2 infection or recent exposure to someone with COVID-19, can cause severe illness including fever, evidence of inflammation, and involvement of multiple bodily systems or organs that can’t be explained by any other cause. Many affected children are quite ill, but fortunately, most recover. The most common body systems affected are the digestive system and the heart and blood vessels.

The MUSIC study is part of a comprehensive Department of Health and Human Services and NIH strategy to understand MIS-C and pediatric COVID-19 as quickly as possible. The study is led by Drs. Jane Newburger of Boston Children’s Hospital and Dongngan Truong of Primary Children’s Hospital, Utah, in collaboration with the Pediatric Heart Network, which is funded by the National Heart, Lung, and Blood Institute. The PHN at Carelon Research will be part of a network-of-networks, including those funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Allergy and Infectious Diseases, to address these important pediatric issues in a rapid manner.

“Few studies have been conducted to characterize MIS-C-associated coronary anatomy or ventricular function in children using standardized assessments, and there are no data about outcomes during longitudinal follow-up,” said Dr. Jane Newburger, Commonwealth Professor of Pediatrics, Harvard Medical School and Associate Cardiologist-in-Chief for Academic Affairs, Children's Hospital Boston.

To address these knowledge gaps, the MUSIC study, which will be conducted in over 29 academic institutions in North America and Canada, will characterize the occurrence and time course of coronary abnormalities, left ventricular dysfunction, systemic non-cardiac organ dysfunction, inflammation, and major medical events in MIS-C. This understanding will support the development of clinical risk stratification models to improve management of the disease course.