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

Autor:	Gross R; Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA., Thaweethai T; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Rosenzweig EB; Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA., Chan J; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Chibnik LB; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Cicek MS; Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Rochester, MN, USA., Elliott AJ; Avera Research Institute, Avera Health, Sioux Falls, SD, USA., Flaherman VJ; Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA., Foulkes AS; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Witvliet MG; Department of Sociology, Lamar University, Beaumont, TX, USA., Gallagher R; Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA., Gennaro ML; Public Health Research Institute and Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA., Jernigan TL; Center for Human Development, Cognitive Science, Psychiatry, Radiology, University of California San Diego, La Jolla, CA, USA., Karlson EW; Department of Medicine, Harvard Medical School, Boston, MA, USA., Katz SD; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Kinser PA; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of Nursing, Richmond, VA, USA., Kleinman LC; Department of Pediatrics, Division of Population Health, Quality, and Implementation Sciences (POPQuIS), Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA., Lamendola-Essel MF; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Milner JD; Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA., Mohandas S; Department of Infectious Diseases, Children's Hospital Los Angeles and the Keck School of Medicine, University of Southern California, Los Angeles, CA, USA., Mudumbi PC; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA., Newburger JW; Department of Cardiology, Boston Children's Hospital, Boston, MA, USA., Rhee KE; Department of Pediatrics, University of California San Diego School of Medicine, San Diego, CA, USA., Salisbury AL; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Snowden JN; Departments of Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Stein CR; Department of Child and Adolescent Psychiatry, Hassenfeld Children's Hospital at NYU Langone, New York, NY, USA., Stockwell MS; Department of Pediatrics, Division of Child and Adolescent Health, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian, New York, NY, USA., Tantisira KG; Division of Pediatric Respiratory Medicine, University of California San Diego, San Diego, CA, USA., Thomason ME; Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA., Truong DT; Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA., Warburton D; Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles, CA, USA., Wood JC; Department of Pediatrics and Radiology, Children's Hospital Los Angeles, Los Angeles, CA, USA., Ahmed S; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Akerlundh A; Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA., Alshawabkeh AN; College of Engineering, Northeastern University, Boston, MA, USA., Anderson BR; Division of Pediatric Cardiology, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA., Aschner JL; Department of Pediatrics, Hackensack University Medical Center, Hackensack, NJ, USA., Atz AM; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA., Aupperle RL; Oxley College of Health Sciences, Laureate Institute for Brain Research, Tulsa, OK, USA., Baker FC; Center for Health Sciences, SRI International, Menlo Park, CA, USA., Balaraman V; Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA., Banerjee D; Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA., Barch DM; Department of Psychological & Brain Sciences, Psychiatry, and Radiology, Washington University in St. Louis, Saint Louis, MO, USA., Baskin-Sommers A; Department of Psychology, Yale University, New Haven, CT, USA., Bhuiyan S; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Bind MC; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Bogie AL; Department of Pediatrics, University of Oklahoma Health Science Center, Oklahoma City, OK, USA., Buchbinder NC; Center for Human Development, University of California San Diego, San Diego, CA, USA., Bueler E; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Bükülmez H; Department of Pediatrics, Division of Rheumatology, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA., Casey BJ; Department of Neuroscience and Behavior, Barnard College - Columbia University, New York, NY, USA., Chang L; Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD, USA., Clark DB; Departments of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA, USA., Clifton RG; Biostatistics Center, George Washington University, Washington, DC, USA., Clouser KN; Department of Pediatrics, Hackensack Meridian School of Medicine, Nutley, NJ, USA., Cottrell L; Department of Pediatrics, West Virginia University, Morgantown, WV, USA., Cowan K; Department of Pediatrics, Robert Larner M.D. College of Medicine at the University of Vermont, Burlington, VT, USA., D'Sa V; Department of Pediatrics, Rhode Island Hospital, Providence, RI, USA., Dapretto M; Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA., Dasgupta S; Department of Pediatrics, Norton Children's Hospital, University of Louisville, Louisville, KY, USA., Dehority W; Department of Pediatrics, Division of Infectious Diseases, University of New Mexico, Albuquerque, NM, USA., Dummer KB; Department of Pediatrics, University of California San Diego, San Diego, CA, USA., Elias MD; Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA., Esquenazi-Karonika S; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA., Evans DN; Arkansas Children's Research Institute, Arkansas Children's Hospital, Little Rock, AR, USA., Faustino EVS; Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA., Fiks AG; Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA., Forsha D; Department of Cardiology, Children's Mercy Kansas City, Ward Family Heart Center, Kansas City, MO, USA, Kansas City, MO, USA., Foxe JJ; Department of Neuroscience, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA., Friedman NP; Institute for Behavioral Genetics and Department of Psychology and Neuroscience, University of Colorado Boulder, Bolder, CO, USA., Fry G; Pennington Biomedical Research Center Clinic, Pennington Biomedical Research Center, Baton Rouge, LA, USA., Gaur S; Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA., Gee DG; Department of Psychology, Yale University, New Haven, CT, USA., Gray KM; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA., Harahsheh AS; Department of Pediatrics, Division of Cardiology, George Washington University School of Medicine & Health Sciences, Washington, DC, USA., Heath AC; Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA., Heitzeg MM; Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA., Hester CM; Division of Practice-Based Research, Innovation, & Evaluation, American Academy of Family Physicians, Leawood, KS, USA., Hill S; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Hobart-Porter L; Departments of Pediatrics and Physical Medicine & Rehabilitation, Section of Pediatric Rehabilitation, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Hong TKF; Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA., Horowitz CR; Center for Health Equity and Community Engaged Research and Department of Population Health Science and Policy, New York, NY, USA., Hsia DS; Clinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA, USA., Huentelman M; Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ, USA., Hummel KD; Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Iacono WG; Department of Psychology, University of Minnesota, Minneapolis, MN, USA., Irby K; Department of Pediatrics, Arkansas Children's Hospital, University of Arkansas Medical School, Little Rock, AR, USA., Jacobus J; Department of Psychiatry, University of California San Diego, La Jolla, CA, USA., Jacoby VL; Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA., Jone PN; Department of Pediatrics, Pediatric Cardiology, Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Kaelber DC; Departments of Pediatrics, Internal Medicine, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, USA., Kasmarcak TJ; Department of Pediatric Clinical Research, Medical University of South Carolina, Charleston, SC, USA., Kluko MJ; Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA., Kosut JS; Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA., Laird AR; Department of Physics, Florida International University, Miami, FL, USA., Landeo-Gutierrez J; Department of Pediatrics, Respiratory Medicine Division, University of California San Diego, San Diego, CA, USA., Lang SM; Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA., Larson CL; Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA., Lim PPC; Department of Pediatric Infectious Disease, Avera McKennan University Health Center, University of South Dakota, Sioux Falls, SD, USA., Lisdahl KM; Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA., McCrindle BW; Department of Pediatrics, University of Toronto, Labatt Family Heart Center, The Hospital for Sick Children, Toronto, ON, Canada., McCulloh RJ; Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE, USA., Mendelsohn AL; Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, New York University Grossman School of Medicine, New York, NY, USA., Metz TD; Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT, USA., Morgan LM; Department of Pediatrics, Valley Children's Healthcare, Department of Pediatrics, Madera, CA, Madera, CA, USA., Müller-Oehring EM; Center for Health Sciences, SRI International, Menlo Park, CA, USA., Nahin ER; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Neale MC; Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA., Ness-Cochinwala M; Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA., Nolan SM; Department of Pediatrics, New York Medical College, Valhalla, NY, USA., Oliveira CR; Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, CT, USA., Oster ME; Department of Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, GA, USA., Payne RM; Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA., Raissy H; Department of Pediatrics, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA., Randall IG; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Rao S; Department of Pediatrics, Division of Infectious Diseases, Epidemiology and Hospital Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA., Reeder HT; Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA., Rosas JM; Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA., Russell MW; Department of Pediatrics, University of Michigan Health System, Ann Arbor, MI, USA., Sabati AA; Department of Pediatric Cardiology, Phoenix Children's Hospital, Phoenix, AZ, USA., Sanil Y; Division of Pediatric Cardiology, Children's Hospital of Michigan, Detroit, MI, USA., Sato AI; Department of Pediatric Infectious Disease, University of Nebraska Medical Center, Omaha, NE, USA., Schechter MS; Department of Pediatrics, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, USA., Selvarangan R; Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA., Shakti D; Department of Pediatrics, Pediatric Cardiology, University of Mississippi Medical Center, Jackson, MS, USA., Sharma K; Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA., Squeglia LM; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA., Stevenson MD; Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA., Szmuszkovicz J; Division of Cardiology, Children's Hospital Los Angeles, Los Angeles, CA, USA., Talavera-Barber MM; Department of Pediatrics, Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA., Teufel RJ 2nd; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA., Thacker D; Nemours Cardiac Center, Nemours Childrens Health, Delaware, Wilmington, DE, USA., Udosen MM; RECOVER Neurocognitive and Wellbeing/Mental Health Team, NYU Grossman School of Medicine, New York, NY, USA., Warner MR; Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA., Watson SE; Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA., Werzberger A; Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA., Weyer JC; Center for Individualized Medicine, Mayo Clinic Hospital, Rochester, MN, USA., Wood MJ; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA., Yin HS; Departments of Pediatrics and Population Health, New York University Grossman School of Medicine, New York, NY, USA., Zempsky WT; Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT, USA., Zimmerman E; Department of Communication Sciences & Disorders, Northeastern University, Boston, MA, USA., Dreyer BP; Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.
Jazyk:	angličtina
Zdroj:	MedRxiv : the preprint server for health sciences [medRxiv] 2023 May 12. Date of Electronic Publication: 2023 May 12.
DOI:	10.1101/2023.04.27.23289228
Abstrakt:	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.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu