This is a preprint.

It has not yet been peer reviewed by a journal.

The National Library of Medicine is running a pilot to include preprints that result from research funded by NIH in PMC and PubMed.

[Preprint]. 2023 May 12:2023.04.27.23289228.

doi: 10.1101/2023.04.27.23289228.

Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design

Rachel Gross¹, Tanayott Thaweethai², Erika B Rosenzweig³, James Chan², Lori B Chibnik², Mine S Cicek⁴, Amy J Elliott⁵, Valerie J Flaherman⁶, Andrea S Foulkes², Margot Gage Witvliet⁷, Richard Gallagher⁸, Maria Laura Gennaro⁹, Terry L Jernigan¹⁰, Elizabeth W Karlson¹¹, Stuart D Katz¹², Patricia A Kinser¹³, Lawrence C Kleinman¹⁴, Michelle F Lamendola-Essel¹², Joshua D Milner¹⁵, Sindhu Mohandas¹⁶, Praveen C Mudumbi¹⁷, Jane W Newburger¹⁸, Kyung E Rhee¹⁹, Amy L Salisbury²⁰, Jessica N Snowden²¹, Cheryl R Stein²², Melissa S Stockwell²³, Kelan G Tantisira²⁴, Moriah E Thomason⁸, Dongngan T Truong²⁵, David Warburton²⁶, John C Wood²⁷, Shifa Ahmed², Almary Akerlundh²⁸, Akram N Alshawabkeh²⁹, Brett R Anderson³⁰, Judy L Aschner³¹, Andrew M Atz³², Robin L Aupperle³³, Fiona C Baker³⁴, Venkataraman Balaraman³⁵, Dithi Banerjee³⁶, Deanna M Barch³⁷, Arielle Baskin-Sommers³⁸, Sultana Bhuiyan¹², Marie-Abele C Bind², Amanda L Bogie³⁹, Natalie C Buchbinder⁴⁰, Elliott Bueler¹², Hülya Bükülmez⁴¹, B J Casey⁴², Linda Chang⁴³, Duncan B Clark⁴⁴, Rebecca G Clifton⁴⁵, Katharine N Clouser⁴⁶, Lesley Cottrell⁴⁷, Kelly Cowan⁴⁸, Viren D'Sa⁴⁹, Mirella Dapretto⁵⁰, Soham Dasgupta⁵¹, Walter Dehority⁵², Kirsten B Dummer⁵³, Matthew D Elias⁵⁴, Shari Esquenazi-Karonika¹⁷, Danielle N Evans⁵⁵, E Vincent S Faustino⁵⁶, Alexander G Fiks⁵⁷, Daniel Forsha⁵⁸, John J Foxe⁵⁹, Naomi P Friedman⁶⁰, Greta Fry⁶¹, Sunanda Gaur⁶², Dylan G Gee³⁸, Kevin M Gray⁶³, Ashraf S Harahsheh⁶⁴, Andrew C Heath⁶⁵, Mary M Heitzeg⁶⁶, Christina M Hester⁶⁷, Sophia Hill¹², Laura Hobart-Porter⁶⁸, Travis K F Hong³⁵, Carol R Horowitz⁶⁹, Daniel S Hsia⁷⁰, Matthew Huentelman⁷¹, Kathy D Hummel⁷², William G Iacono⁷³, Katherine Irby⁷⁴, Joanna Jacobus⁷⁵, Vanessa L Jacoby⁷⁶, Pei-Ni Jone⁷⁷, David C Kaelber⁷⁸, Tyler J Kasmarcak⁷⁹, Matthew J Kluko⁵⁶, Jessica S Kosut³⁵, Angela R Laird⁸⁰, Jeremy Landeo-Gutierrez⁸¹, Sean M Lang⁸², Christine L Larson⁸³, Peter Paul C Lim⁸⁴, Krista M Lisdahl⁸³, Brian W McCrindle⁸⁵, Russell J McCulloh⁸⁶, Alan L Mendelsohn⁸⁷, Torri D Metz⁸⁸, Lerraughn M Morgan⁸⁹, Eva M Müller-Oehring³⁴, Erica R Nahin¹², Michael C Neale⁹⁰, Manette Ness-Cochinwala⁶², Sheila M Nolan⁹¹, Carlos R Oliveira⁹², Matthew E Oster⁹³, R Mark Payne⁹⁴, Hengameh Raissy⁹⁵, Isabelle G Randall¹², Suchitra Rao⁹⁶, Harrison T Reeder², Johana M Rosas¹², Mark W Russell⁹⁷, Arash A Sabati⁹⁸, Yamuna Sanil⁹⁹, Alice I Sato¹⁰⁰, Michael S Schechter¹⁰¹, Rangaraj Selvarangan³⁶, Divya Shakti¹⁰², Kavita Sharma¹⁰³, Lindsay M Squeglia⁶³, Michelle D Stevenson¹⁰⁴, Jacqueline Szmuszkovicz¹⁰⁵, Maria M Talavera-Barber¹⁰⁶, Ronald J Teufel 2nd³², Deepika Thacker¹⁰⁷, Mmekom M Udosen¹⁰⁸, Megan R Warner²⁸, Sara E Watson¹⁰⁴, Alan Werzberger¹⁵, Jordan C Weyer¹⁰⁹, Marion J Wood¹⁷, H Shonna Yin¹¹⁰, William T Zempsky¹¹¹, Emily Zimmerman¹¹², Benard P Dreyer¹

Affiliations

¹ Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
² Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.
³ Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
⁴ Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Rochester, MN, USA.
⁵ Avera Research Institute, Avera Health, Sioux Falls, SD, USA.
⁶ Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.
⁷ Department of Sociology, Lamar University, Beaumont, TX, USA.
⁸ Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA.
⁹ Public Health Research Institute and Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
¹⁰ Center for Human Development, Cognitive Science, Psychiatry, Radiology, University of California San Diego, La Jolla, CA, USA.
¹¹ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹² Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.
¹³ Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of Nursing, Richmond, VA, USA.
¹⁴ Department of Pediatrics, Division of Population Health, Quality, and Implementation Sciences (POPQuIS), Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
¹⁵ Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA.
¹⁶ Department of Infectious Diseases, Children's Hospital Los Angeles and the Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
¹⁷ Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.
¹⁸ Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.
¹⁹ Department of Pediatrics, University of California San Diego School of Medicine, San Diego, CA, USA.
²⁰ School of Nursing, Virginia Commonwealth University, Richmond, VA, USA.
²¹ Departments of Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
²² Department of Child and Adolescent Psychiatry, Hassenfeld Children's Hospital at NYU Langone, New York, NY, USA.
²³ Department of Pediatrics, Division of Child and Adolescent Health, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, NY, USA.
²⁴ Division of Pediatric Respiratory Medicine, University of California San Diego, San Diego, CA, USA.
²⁵ Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.
²⁶ Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles, CA, USA.
²⁷ Department of Pediatrics and Radiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.
²⁸ Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA.
²⁹ College of Engineering, Northeastern University, Boston, MA, USA.
³⁰ Division of Pediatric Cardiology, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA.
³¹ Department of Pediatrics, Hackensack University Medical Center, Hackensack, NJ, USA.
³² Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
³³ Oxley College of Health Sciences, Laureate Institute for Brain Research, Tulsa, OK, USA.
³⁴ Center for Health Sciences, SRI International, Menlo Park, CA, USA.
³⁵ Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA.
³⁶ Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA.
³⁷ Department of Psychological & Brain Sciences, Psychiatry, and Radiology, Washington University in St. Louis, Saint Louis, MO, USA.
³⁸ Department of Psychology, Yale University, New Haven, CT, USA.
³⁹ Department of Pediatrics, University of Oklahoma Health Science Center, Oklahoma City, OK, USA.
⁴⁰ Center for Human Development, University of California San Diego, San Diego, CA, USA.
⁴¹ Department of Pediatrics, Division of Rheumatology, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA.
⁴² Department of Neuroscience and Behavior, Barnard College - Columbia University, New York, NY, USA.
⁴³ Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
⁴⁴ Departments of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
⁴⁵ Biostatistics Center, George Washington University, Washington, DC, USA.
⁴⁶ Department of Pediatrics, Hackensack Meridian School of Medicine, Nutley, NJ, USA.
⁴⁷ Department of Pediatrics, West Virginia University, Morgantown, WV, USA.
⁴⁸ Department of Pediatrics, Robert Larner M.D. College of Medicine at the University of Vermont, Burlington, VT, USA.
⁴⁹ Department of Pediatrics, Rhode Island Hospital, Providence, RI, USA.
⁵⁰ Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.
⁵¹ Department of Pediatrics, Norton Children's Hospital, University of Louisville, Louisville, KY, USA.
⁵² Department of Pediatrics, Division of Infectious Diseases, University of New Mexico, Albuquerque, NM, USA.
⁵³ Department of Pediatrics, University of California San Diego, San Diego, CA, USA.
⁵⁴ Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁵⁵ Arkansas Children's Research Institute, Arkansas Children's Hospital, Little Rock, AR, USA.
⁵⁶ Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA.
⁵⁷ Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁵⁸ Department of Cardiology, Children's Mercy Kansas City, Ward Family Heart Center, Kansas City, MO, USA, Kansas City, MO, USA.
⁵⁹ Department of Neuroscience, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
⁶⁰ Institute for Behavioral Genetics and Department of Psychology and Neuroscience, University of Colorado Boulder, Bolder, CO, USA.
⁶¹ Pennington Biomedical Research Center Clinic, Pennington Biomedical Research Center, Baton Rouge, LA, USA.
⁶² Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
⁶³ Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
⁶⁴ Department of Pediatrics, Division of Cardiology, George Washington University School of Medicine & Health Sciences, Washington, DC, USA.
⁶⁵ Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA.
⁶⁶ Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
⁶⁷ Division of Practice-Based Research, Innovation, & Evaluation, American Academy of Family Physicians, Leawood, KS, USA.
⁶⁸ Departments of Pediatrics and Physical Medicine & Rehabilitation, Section of Pediatric Rehabilitation, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
⁶⁹ Center for Health Equity and Community Engaged Research and Department of Population Health Science and Policy, New York, NY, USA.
⁷⁰ Clinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA, USA.
⁷¹ Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ, USA.
⁷² Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
⁷³ Department of Psychology, University of Minnesota, Minneapolis, MN, USA.
⁷⁴ Department of Pediatrics, Arkansas Children's Hospital, University of Arkansas Medical School, Little Rock, AR, USA.
⁷⁵ Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.
⁷⁶ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
⁷⁷ Department of Pediatrics, Pediatric Cardiology, Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
⁷⁸ Departments of Pediatrics, Internal Medicine, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, USA.
⁷⁹ Department of Pediatric Clinical Research, Medical University of South Carolina, Charleston, SC, USA.
⁸⁰ Department of Physics, Florida International University, Miami, FL, USA.
⁸¹ Department of Pediatrics, Respiratory Medicine Division, University of California San Diego, San Diego, CA, USA.
⁸² Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
⁸³ Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.
⁸⁴ Department of Pediatric Infectious Disease, Avera McKennan University Health Center, University of South Dakota, Sioux Falls, SD, USA.
⁸⁵ Department of Pediatrics, University of Toronto, Labatt Family Heart Center, The Hospital for Sick Children, Toronto, ON, Canada.
⁸⁶ Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE, USA.
⁸⁷ Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
⁸⁸ Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT, USA.
⁸⁹ Department of Pediatrics, Valley Children's Healthcare, Department of Pediatrics, Madera, CA, Madera, CA, USA.
⁹⁰ Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.
⁹¹ Department of Pediatrics, New York Medical College, Valhalla, NY, USA.
⁹² Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, CT, USA.
⁹³ Department of Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, GA, USA.
⁹⁴ Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.
⁹⁵ Department of Pediatrics, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA.
⁹⁶ Department of Pediatrics, Division of Infectious Diseases, Epidemiology and Hospital Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁹⁷ Department of Pediatrics, University of Michigan Health System, Ann Arbor, MI, USA.
⁹⁸ Department of Pediatric Cardiology, Phoenix Children's Hospital, Phoenix, AZ, USA.
⁹⁹ Division of Pediatric Cardiology, Children's Hospital of Michigan, Detroit, MI, USA.
¹⁰⁰ Department of Pediatric Infectious Disease, University of Nebraska Medical Center, Omaha, NE, USA.
¹⁰¹ Department of Pediatrics, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, USA.
¹⁰² Department of Pediatrics, Pediatric Cardiology, University of Mississippi Medical Center, Jackson, MS, USA.
¹⁰³ Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
¹⁰⁴ Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA.
¹⁰⁵ Division of Cardiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.
¹⁰⁶ Department of Pediatrics, Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA.
¹⁰⁷ Nemours Cardiac Center, Nemours Childrens Health, Delaware, Wilmington, DE, USA.
¹⁰⁸ RECOVER Neurocognitive and Wellbeing/Mental Health Team, NYU Grossman School of Medicine, New York, NY, USA.
¹⁰⁹ Center for Individualized Medicine, Mayo Clinic Hospital, Rochester, MN, USA.
¹¹⁰ Departments of Pediatrics and Population Health, New York University Grossman School of Medicine, New York, NY, USA.
¹¹¹ Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT, USA.
¹¹² Department of Communication Sciences & Disorders, Northeastern University, Boston, MA, USA.

PMID: 37214806
PMCID: PMC10197716
DOI: 10.1101/2023.04.27.23289228

Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design

Rachel Gross et al. medRxiv. 2023.

[Preprint]. 2023 May 12:2023.04.27.23289228.

doi: 10.1101/2023.04.27.23289228.

Authors

Affiliations

¹ Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
² Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.
³ Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.
⁴ Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Rochester, MN, USA.
⁵ Avera Research Institute, Avera Health, Sioux Falls, SD, USA.
⁶ Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.
⁷ Department of Sociology, Lamar University, Beaumont, TX, USA.
⁸ Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA.
⁹ Public Health Research Institute and Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
¹⁰ Center for Human Development, Cognitive Science, Psychiatry, Radiology, University of California San Diego, La Jolla, CA, USA.
¹¹ Department of Medicine, Harvard Medical School, Boston, MA, USA.
¹² Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.
¹³ Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of Nursing, Richmond, VA, USA.
¹⁴ Department of Pediatrics, Division of Population Health, Quality, and Implementation Sciences (POPQuIS), Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
¹⁵ Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA.
¹⁶ Department of Infectious Diseases, Children's Hospital Los Angeles and the Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
¹⁷ Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.
¹⁸ Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.
¹⁹ Department of Pediatrics, University of California San Diego School of Medicine, San Diego, CA, USA.
²⁰ School of Nursing, Virginia Commonwealth University, Richmond, VA, USA.
²¹ Departments of Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
²² Department of Child and Adolescent Psychiatry, Hassenfeld Children's Hospital at NYU Langone, New York, NY, USA.
²³ Department of Pediatrics, Division of Child and Adolescent Health, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, NY, USA.
²⁴ Division of Pediatric Respiratory Medicine, University of California San Diego, San Diego, CA, USA.
²⁵ Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.
²⁶ Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles, CA, USA.
²⁷ Department of Pediatrics and Radiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.
²⁸ Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA.
²⁹ College of Engineering, Northeastern University, Boston, MA, USA.
³⁰ Division of Pediatric Cardiology, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA.
³¹ Department of Pediatrics, Hackensack University Medical Center, Hackensack, NJ, USA.
³² Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
³³ Oxley College of Health Sciences, Laureate Institute for Brain Research, Tulsa, OK, USA.
³⁴ Center for Health Sciences, SRI International, Menlo Park, CA, USA.
³⁵ Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA.
³⁶ Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA.
³⁷ Department of Psychological & Brain Sciences, Psychiatry, and Radiology, Washington University in St. Louis, Saint Louis, MO, USA.
³⁸ Department of Psychology, Yale University, New Haven, CT, USA.
³⁹ Department of Pediatrics, University of Oklahoma Health Science Center, Oklahoma City, OK, USA.
⁴⁰ Center for Human Development, University of California San Diego, San Diego, CA, USA.
⁴¹ Department of Pediatrics, Division of Rheumatology, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA.
⁴² Department of Neuroscience and Behavior, Barnard College - Columbia University, New York, NY, USA.
⁴³ Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
⁴⁴ Departments of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA, USA.
⁴⁵ Biostatistics Center, George Washington University, Washington, DC, USA.
⁴⁶ Department of Pediatrics, Hackensack Meridian School of Medicine, Nutley, NJ, USA.
⁴⁷ Department of Pediatrics, West Virginia University, Morgantown, WV, USA.
⁴⁸ Department of Pediatrics, Robert Larner M.D. College of Medicine at the University of Vermont, Burlington, VT, USA.
⁴⁹ Department of Pediatrics, Rhode Island Hospital, Providence, RI, USA.
⁵⁰ Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.
⁵¹ Department of Pediatrics, Norton Children's Hospital, University of Louisville, Louisville, KY, USA.
⁵² Department of Pediatrics, Division of Infectious Diseases, University of New Mexico, Albuquerque, NM, USA.
⁵³ Department of Pediatrics, University of California San Diego, San Diego, CA, USA.
⁵⁴ Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁵⁵ Arkansas Children's Research Institute, Arkansas Children's Hospital, Little Rock, AR, USA.
⁵⁶ Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA.
⁵⁷ Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁵⁸ Department of Cardiology, Children's Mercy Kansas City, Ward Family Heart Center, Kansas City, MO, USA, Kansas City, MO, USA.
⁵⁹ Department of Neuroscience, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
⁶⁰ Institute for Behavioral Genetics and Department of Psychology and Neuroscience, University of Colorado Boulder, Bolder, CO, USA.
⁶¹ Pennington Biomedical Research Center Clinic, Pennington Biomedical Research Center, Baton Rouge, LA, USA.
⁶² Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
⁶³ Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
⁶⁴ Department of Pediatrics, Division of Cardiology, George Washington University School of Medicine & Health Sciences, Washington, DC, USA.
⁶⁵ Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA.
⁶⁶ Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.
⁶⁷ Division of Practice-Based Research, Innovation, & Evaluation, American Academy of Family Physicians, Leawood, KS, USA.
⁶⁸ Departments of Pediatrics and Physical Medicine & Rehabilitation, Section of Pediatric Rehabilitation, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
⁶⁹ Center for Health Equity and Community Engaged Research and Department of Population Health Science and Policy, New York, NY, USA.
⁷⁰ Clinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA, USA.
⁷¹ Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ, USA.
⁷² Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
⁷³ Department of Psychology, University of Minnesota, Minneapolis, MN, USA.
⁷⁴ Department of Pediatrics, Arkansas Children's Hospital, University of Arkansas Medical School, Little Rock, AR, USA.
⁷⁵ Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.
⁷⁶ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
⁷⁷ Department of Pediatrics, Pediatric Cardiology, Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
⁷⁸ Departments of Pediatrics, Internal Medicine, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, USA.
⁷⁹ Department of Pediatric Clinical Research, Medical University of South Carolina, Charleston, SC, USA.
⁸⁰ Department of Physics, Florida International University, Miami, FL, USA.
⁸¹ Department of Pediatrics, Respiratory Medicine Division, University of California San Diego, San Diego, CA, USA.
⁸² Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
⁸³ Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.
⁸⁴ Department of Pediatric Infectious Disease, Avera McKennan University Health Center, University of South Dakota, Sioux Falls, SD, USA.
⁸⁵ Department of Pediatrics, University of Toronto, Labatt Family Heart Center, The Hospital for Sick Children, Toronto, ON, Canada.
⁸⁶ Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE, USA.
⁸⁷ Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
⁸⁸ Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT, USA.
⁸⁹ Department of Pediatrics, Valley Children's Healthcare, Department of Pediatrics, Madera, CA, Madera, CA, USA.
⁹⁰ Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.
⁹¹ Department of Pediatrics, New York Medical College, Valhalla, NY, USA.
⁹² Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, CT, USA.
⁹³ Department of Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, GA, USA.
⁹⁴ Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.
⁹⁵ Department of Pediatrics, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA.
⁹⁶ Department of Pediatrics, Division of Infectious Diseases, Epidemiology and Hospital Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁹⁷ Department of Pediatrics, University of Michigan Health System, Ann Arbor, MI, USA.
⁹⁸ Department of Pediatric Cardiology, Phoenix Children's Hospital, Phoenix, AZ, USA.
⁹⁹ Division of Pediatric Cardiology, Children's Hospital of Michigan, Detroit, MI, USA.
¹⁰⁰ Department of Pediatric Infectious Disease, University of Nebraska Medical Center, Omaha, NE, USA.
¹⁰¹ Department of Pediatrics, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, USA.
¹⁰² Department of Pediatrics, Pediatric Cardiology, University of Mississippi Medical Center, Jackson, MS, USA.
¹⁰³ Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
¹⁰⁴ Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA.
¹⁰⁵ Division of Cardiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.
¹⁰⁶ Department of Pediatrics, Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA.
¹⁰⁷ Nemours Cardiac Center, Nemours Childrens Health, Delaware, Wilmington, DE, USA.
¹⁰⁸ RECOVER Neurocognitive and Wellbeing/Mental Health Team, NYU Grossman School of Medicine, New York, NY, USA.
¹⁰⁹ Center for Individualized Medicine, Mayo Clinic Hospital, Rochester, MN, USA.
¹¹⁰ Departments of Pediatrics and Population Health, New York University Grossman School of Medicine, New York, NY, USA.
¹¹¹ Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT, USA.
¹¹² Department of Communication Sciences & Disorders, Northeastern University, Boston, MA, USA.

PMID: 37214806
PMCID: PMC10197716
DOI: 10.1101/2023.04.27.23289228

Update in

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.
Horwitz LI, Thaweethai T, Brosnahan SB, Cicek MS, Fitzgerald ML, Goldman JD, Hess R, Hodder SL, Jacoby VL, Jordan MR, Krishnan JA, Laiyemo AO, Metz TD, Nichols L, Patzer RE, Sekar A, Singer NG, Stiles LE, Taylor BS, Ahmed S, Algren HA, Anglin K, Aponte-Soto L, Ashktorab H, Bassett IV, Bedi B, Bhadelia N, Bime C, Bind MC, Black LJ, Blomkalns AL, Brim H, Castro M, Chan J, Charney AW, Chen BK, Chen LQ, Chen P, Chestek D, Chibnik LB, Chow DC, Chu HY, Clifton RG, Collins S, Costantine MM, Cribbs SK, Deeks SG, Dickinson JD, Donohue SE, Durstenfeld MS, Emery IF, Erlandson KM, Facelli JC, Farah-Abraham R, Finn AV, Fischer MS, Flaherman VJ, Fleurimont J, Fonseca V, Gallagher EJ, Gander JC, Gennaro ML, Gibson KS, Go M, Goodman SN, Granger JP, Greenway FL, Hafner JW, Han JE, Harkins MS, Hauser KSP, Heath JR, Hernandez CR, Ho O, Hoffman MK, Hoover SE, Horowitz CR, Hsu H, Hsue PY, Hughes BL, Jagannathan P, James JA, John J, Jolley S, Judd SE, Juskowich JJ, Kanjilal DG, Karlson EW, Katz SD, Kelly JD, Kelly SW, Kim AY, Kirwan JP, Knox KS, Kumar A, Lamendola-Essel MF, Lanca M, Lee-Lannotti JK, Lefebvre RC, Levy BD, Lin JY, Logarbo BP Jr, Logue JK, Longo MT, Luciano CA, Lutrick K, Malakooti SK, Ma… See abstract for full author list ➔ Horwitz LI, et al. PLoS One. 2023 Jun 23;18(6):e0286297. doi: 10.1371/journal.pone.0286297. eCollection 2023. PLoS One. 2023. PMID: 37352211 Free PMC article.

Abstract

Importance: The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.

Observations: We describe the protocol for the Pediatric Observational Cohort Study of the NIH's RE searching COV ID to E nhance R ecovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of five cohorts that comprise RECOVER-Pediatrics: 1) a de novo RECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study ( n =10,000). The de novo cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science.

Conclusions and relevance: RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions.

Clinical trialsgov identifier: Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.

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Conflict of interest statement

Competing interests

Brett Anderson reported receiving direct support for work not related to RECOVER work/publications from Genentech and the National Institute of Allergy and Immunology.

Walter Dehority reported receiving grant support from Merck and participating in research for the Moderna COVID-19 pediatric vaccine trial and the Pfizer Paxlovid trial.

Alex Fiks reported receiving support from NJM insurance and personal consulting fees not related to this paper from Rutgers University and the American Academy of Pediatrics.

Ashraf Harahsheh reported serving as a scientific advisory board member unrelated to this paper for OP2 DRUGS.

Lawrence Kleinman reported serving as an unpaid member of the Board of Directors for the DARTNet Institute, as a principle investigator at Quality Matters, Inc., and as the Vice Chair for the Borough of Metuchen Board of Health. Dr. Kleinman also reported grant support for work not related to RECOVER work/publications from NIH, HRSA, and the Robert Wood Johnson Foundation. Dr. Kleinman also reported minority individual stock ownership in Apple Computer, Sanofi SA, Experion, GlaxoSmithKline, Magyar Bank, Regeneron Pharmaceuticals, JP Morgan Chase, and Amgen Inc.

Torri Metz reported participating as a Principle Investigator in the medical advisory board for the planning of a Pfizer clinical trial of SARS-CoV-2 vaccination in pregnancy. She is also a principle investigator for a Pfizer study evaluating the pharmacokinetics of Paxlovid in pregnant people with COVID-19.

Joshua Milner reported serving as a member of the Scientific Advisory Board for Blueprint Medicines, in a capacity unrelated to RECOVER work/publications.

Figures

**Fig 1:**
Overview of RECOVER-Pediatrics (de novo and ABCD cohorts).

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References

1. Davis HE, McCorkell L, Vogel JM, Topol EJ. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol. 2023;21(3):133–46. Epub 20230113. doi: 10.1038/s41579-022-00846-2. - DOI - PMC - PubMed
1. World Health Organization. WHO Coronavirus (COVID-19) dashboard 2023 2023. Available from: https://covid19.who.int/.
1. Zimmermann P, Pittet LF, Curtis N. How common is Long COVID in children and adolescents? Pediatr Infect Dis J. 2021;40(12):e482–e7. doi: 10.1097/inf.0000000000003328. - DOI - PMC - PubMed
1. Kompaniyets L, Bull-Otterson L, Boehmer TK, Baca S, Alvarez P, Hong K, et al. Post-COVID-19 symptoms and conditions among children and adolescents - United States, March 1, 2020-January 31, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(31):993–9. Epub 20220805. doi: 10.15585/mmwr.mm7131a3. - DOI - PMC - PubMed
1. Borch L, Holm M, Knudsen M, Ellermann-Eriksen S, Hagstroem S. Long COVID symptoms and duration in SARS-CoV-2 positive children - a nationwide cohort study. Eur J Pediatr. 2022;181(4):1597–607. Epub 20220109. doi: 10.1007/s00431-021-04345-z. - DOI - PMC - PubMed

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Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design

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