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

Journal

medRxiv : the preprint server for health sciences
Titre abrégé: medRxiv
Pays: United States
ID NLM: 101767986

Informations de publication

Date de publication:
12 May 2023
Historique:
medline: 22 5 2023
pubmed: 22 5 2023
entrez: 22 5 2023
Statut: epublish

Résumé

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. We describe the protocol for the Pediatric Observational Cohort Study of the NIH's 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 Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.

Identifiants

DOI: 10.1101/2023.04.27.23289228 PMID: 37214806 PMC: PMC10197716
pubmed: 37214806
doi: 10.1101/2023.04.27.23289228
pmc: PMC10197716
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT05172011']

Types de publication

Preprint

Langues

eng

Subventions

Organisme : NIAID NIH HHS
ID : K23 AI159518
Pays : United States
Organisme : NHLBI NIH HHS
ID : OT2 HL161847
Pays : United States

Commentaires et corrections

Type : UpdateIn

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Auteurs

Rachel Gross (R)

Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.

Tanayott Thaweethai (T)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Erika B Rosenzweig (EB)

Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.

James Chan (J)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Lori B Chibnik (LB)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Mine S Cicek (MS)

Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Rochester, MN, USA.

Amy J Elliott (AJ)

Avera Research Institute, Avera Health, Sioux Falls, SD, USA.

Valerie J Flaherman (VJ)

Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.

Andrea S Foulkes (AS)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Margot Gage Witvliet (MG)

Department of Sociology, Lamar University, Beaumont, TX, USA.

Richard Gallagher (R)

Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA.

Maria Laura Gennaro (ML)

Public Health Research Institute and Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.

Terry L Jernigan (TL)

Center for Human Development, Cognitive Science, Psychiatry, Radiology, University of California San Diego, La Jolla, CA, USA.

Elizabeth W Karlson (EW)

Department of Medicine, Harvard Medical School, Boston, MA, USA.

Stuart D Katz (SD)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Patricia A Kinser (PA)

Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of Nursing, Richmond, VA, USA.

Lawrence C Kleinman (LC)

Department of Pediatrics, Division of Population Health, Quality, and Implementation Sciences (POPQuIS), Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.

Michelle F Lamendola-Essel (MF)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Joshua D Milner (JD)

Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA.

Sindhu 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.

Praveen C Mudumbi (PC)

Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.

Jane W Newburger (JW)

Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.

Kyung E Rhee (KE)

Department of Pediatrics, University of California San Diego School of Medicine, San Diego, CA, USA.

Amy L Salisbury (AL)

School of Nursing, Virginia Commonwealth University, Richmond, VA, USA.

Jessica N Snowden (JN)

Departments of Pediatrics and Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Cheryl R Stein (CR)

Department of Child and Adolescent Psychiatry, Hassenfeld Children's Hospital at NYU Langone, New York, NY, USA.

Melissa S 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.

Kelan G Tantisira (KG)

Division of Pediatric Respiratory Medicine, University of California San Diego, San Diego, CA, USA.

Moriah E Thomason (ME)

Department of Child and Adolescent Psychiatry, New York University Grossman School of Medicine, New York, NY, USA.

Dongngan T Truong (DT)

Division of Pediatric Cardiology, University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA.

David Warburton (D)

Department of Pediatrics, Children's Hospital Los Angeles, Los Angeles, CA, USA.

John C Wood (JC)

Department of Pediatrics and Radiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.

Shifa Ahmed (S)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Almary Akerlundh (A)

Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA.

Akram N Alshawabkeh (AN)

College of Engineering, Northeastern University, Boston, MA, USA.

Brett R Anderson (BR)

Division of Pediatric Cardiology, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY, USA.

Judy L Aschner (JL)

Department of Pediatrics, Hackensack University Medical Center, Hackensack, NJ, USA.

Andrew M Atz (AM)

Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.

Robin L Aupperle (RL)

Oxley College of Health Sciences, Laureate Institute for Brain Research, Tulsa, OK, USA.

Fiona C Baker (FC)

Center for Health Sciences, SRI International, Menlo Park, CA, USA.

Venkataraman Balaraman (V)

Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA.

Dithi Banerjee (D)

Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA.

Deanna M Barch (DM)

Department of Psychological & Brain Sciences, Psychiatry, and Radiology, Washington University in St. Louis, Saint Louis, MO, USA.

Arielle Baskin-Sommers (A)

Department of Psychology, Yale University, New Haven, CT, USA.

Sultana Bhuiyan (S)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Marie-Abele C Bind (MC)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Amanda L Bogie (AL)

Department of Pediatrics, University of Oklahoma Health Science Center, Oklahoma City, OK, USA.

Natalie C Buchbinder (NC)

Center for Human Development, University of California San Diego, San Diego, CA, USA.

Elliott Bueler (E)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Hülya Bükülmez (H)

Department of Pediatrics, Division of Rheumatology, The MetroHealth System, Case Western Reserve University, Cleveland, OH, USA.

B J Casey (BJ)

Department of Neuroscience and Behavior, Barnard College - Columbia University, New York, NY, USA.

Linda Chang (L)

Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.

Duncan B Clark (DB)

Departments of Psychiatry and Pharmaceutical Sciences, University of Pittsburgh, Pittsburgh, PA, USA.

Rebecca G Clifton (RG)

Biostatistics Center, George Washington University, Washington, DC, USA.

Katharine N Clouser (KN)

Department of Pediatrics, Hackensack Meridian School of Medicine, Nutley, NJ, USA.

Lesley Cottrell (L)

Department of Pediatrics, West Virginia University, Morgantown, WV, USA.

Kelly Cowan (K)

Department of Pediatrics, Robert Larner M.D. College of Medicine at the University of Vermont, Burlington, VT, USA.

Viren D'Sa (V)

Department of Pediatrics, Rhode Island Hospital, Providence, RI, USA.

Mirella Dapretto (M)

Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA.

Soham Dasgupta (S)

Department of Pediatrics, Norton Children's Hospital, University of Louisville, Louisville, KY, USA.

Walter Dehority (W)

Department of Pediatrics, Division of Infectious Diseases, University of New Mexico, Albuquerque, NM, USA.

Kirsten B Dummer (KB)

Department of Pediatrics, University of California San Diego, San Diego, CA, USA.

Matthew D Elias (MD)

Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Shari Esquenazi-Karonika (S)

Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.

Danielle N Evans (DN)

Arkansas Children's Research Institute, Arkansas Children's Hospital, Little Rock, AR, USA.

E Vincent S Faustino (EVS)

Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA.

Alexander G Fiks (AG)

Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Daniel Forsha (D)

Department of Cardiology, Children's Mercy Kansas City, Ward Family Heart Center, Kansas City, MO, USA, Kansas City, MO, USA.

John J Foxe (JJ)

Department of Neuroscience, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.

Naomi P Friedman (NP)

Institute for Behavioral Genetics and Department of Psychology and Neuroscience, University of Colorado Boulder, Bolder, CO, USA.

Greta Fry (G)

Pennington Biomedical Research Center Clinic, Pennington Biomedical Research Center, Baton Rouge, LA, USA.

Sunanda Gaur (S)

Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.

Dylan G Gee (DG)

Department of Psychology, Yale University, New Haven, CT, USA.

Kevin M Gray (KM)

Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.

Ashraf S Harahsheh (AS)

Department of Pediatrics, Division of Cardiology, George Washington University School of Medicine & Health Sciences, Washington, DC, USA.

Andrew C Heath (AC)

Department of Psychiatry, Washington University School of Medicine, St Louis, MO, USA.

Mary M Heitzeg (MM)

Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.

Christina M Hester (CM)

Division of Practice-Based Research, Innovation, & Evaluation, American Academy of Family Physicians, Leawood, KS, USA.

Sophia Hill (S)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Laura Hobart-Porter (L)

Departments of Pediatrics and Physical Medicine & Rehabilitation, Section of Pediatric Rehabilitation, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Travis K F Hong (TKF)

Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA.

Carol R Horowitz (CR)

Center for Health Equity and Community Engaged Research and Department of Population Health Science and Policy, New York, NY, USA.

Daniel S Hsia (DS)

Clinical Trials Unit, Pennington Biomedical Research Center, Baton Rouge, LA, USA.

Matthew Huentelman (M)

Division of Neurogenomics, Translational Genomics Research Institute, Phoenix, AZ, USA.

Kathy D Hummel (KD)

Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

William G Iacono (WG)

Department of Psychology, University of Minnesota, Minneapolis, MN, USA.

Katherine Irby (K)

Department of Pediatrics, Arkansas Children's Hospital, University of Arkansas Medical School, Little Rock, AR, USA.

Joanna Jacobus (J)

Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.

Vanessa L Jacoby (VL)

Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.

Pei-Ni Jone (PN)

Department of Pediatrics, Pediatric Cardiology, Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

David C Kaelber (DC)

Departments of Pediatrics, Internal Medicine, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, USA.

Tyler J Kasmarcak (TJ)

Department of Pediatric Clinical Research, Medical University of South Carolina, Charleston, SC, USA.

Matthew J Kluko (MJ)

Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA.

Jessica S Kosut (JS)

Department of Pediatrics, Kapiolani Medical Center for Women and Children, Honolulu, HI, USA.

Angela R Laird (AR)

Department of Physics, Florida International University, Miami, FL, USA.

Jeremy Landeo-Gutierrez (J)

Department of Pediatrics, Respiratory Medicine Division, University of California San Diego, San Diego, CA, USA.

Sean M Lang (SM)

Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.

Christine L Larson (CL)

Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.

Peter Paul C Lim (PPC)

Department of Pediatric Infectious Disease, Avera McKennan University Health Center, University of South Dakota, Sioux Falls, SD, USA.

Krista M Lisdahl (KM)

Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.

Brian W McCrindle (BW)

Department of Pediatrics, University of Toronto, Labatt Family Heart Center, The Hospital for Sick Children, Toronto, ON, Canada.

Russell J McCulloh (RJ)

Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE, USA.

Alan L Mendelsohn (AL)

Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.

Torri D Metz (TD)

Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT, USA.

Lerraughn M Morgan (LM)

Department of Pediatrics, Valley Children's Healthcare, Department of Pediatrics, Madera, CA, Madera, CA, USA.

Eva M Müller-Oehring (EM)

Center for Health Sciences, SRI International, Menlo Park, CA, USA.

Erica R Nahin (ER)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Michael C Neale (MC)

Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.

Manette Ness-Cochinwala (M)

Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.

Sheila M Nolan (SM)

Department of Pediatrics, New York Medical College, Valhalla, NY, USA.

Carlos R Oliveira (CR)

Department of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of Medicine, New Haven, CT, USA.

Matthew E Oster (ME)

Department of Pediatric Cardiology, Children's Healthcare of Atlanta, Atlanta, GA, USA.

R Mark Payne (RM)

Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.

Hengameh Raissy (H)

Department of Pediatrics, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA.

Isabelle G Randall (IG)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Suchitra Rao (S)

Department of Pediatrics, Division of Infectious Diseases, Epidemiology and Hospital Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Harrison T Reeder (HT)

Department of Biostatistics, Massachusetts General Hospital, Boston, MA, USA.

Johana M Rosas (JM)

Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA.

Mark W Russell (MW)

Department of Pediatrics, University of Michigan Health System, Ann Arbor, MI, USA.

Arash A Sabati (AA)

Department of Pediatric Cardiology, Phoenix Children's Hospital, Phoenix, AZ, USA.

Yamuna Sanil (Y)

Division of Pediatric Cardiology, Children's Hospital of Michigan, Detroit, MI, USA.

Alice I Sato (AI)

Department of Pediatric Infectious Disease, University of Nebraska Medical Center, Omaha, NE, USA.

Michael S Schechter (MS)

Department of Pediatrics, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, VA, USA.

Rangaraj Selvarangan (R)

Department of Pathology and Laboratory Medicine, Children's Mercy Hospital, Kansas City, MO, USA.

Divya Shakti (D)

Department of Pediatrics, Pediatric Cardiology, University of Mississippi Medical Center, Jackson, MS, USA.

Kavita Sharma (K)

Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Lindsay M Squeglia (LM)

Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.

Michelle D Stevenson (MD)

Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA.

Jacqueline Szmuszkovicz (J)

Division of Cardiology, Children's Hospital Los Angeles, Los Angeles, CA, USA.

Maria M Talavera-Barber (MM)

Department of Pediatrics, Avera McKennan Hospital and University Health Center, Sioux Falls, SD, USA.

Ronald J Teufel (RJ)

Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.

Deepika Thacker (D)

Nemours Cardiac Center, Nemours Childrens Health, Delaware, Wilmington, DE, USA.

Mmekom M Udosen (MM)

RECOVER Neurocognitive and Wellbeing/Mental Health Team, NYU Grossman School of Medicine, New York, NY, USA.

Megan R Warner (MR)

Department of Pulmonary Research, Rady Children's Hospital-San Diego, San Diego, CA, USA.

Sara E Watson (SE)

Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA.

Alan Werzberger (A)

Department of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical Center, New York, NY, USA.

Jordan C Weyer (JC)

Center for Individualized Medicine, Mayo Clinic Hospital, Rochester, MN, USA.

Marion J Wood (MJ)

Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.

H Shonna Yin (HS)

Departments of Pediatrics and Population Health, New York University Grossman School of Medicine, New York, NY, USA.

William T Zempsky (WT)

Department of Pediatrics, Connecticut Children's Medical Center, Hartford, CT, USA.

Emily Zimmerman (E)

Department of Communication Sciences & Disorders, Northeastern University, Boston, MA, USA.

Benard P Dreyer (BP)

Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.

Classifications MeSH