Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Abstract ImportanceThe 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. ObservationsWe describe the protocol for the Pediatric Observational Cohort Study of the NIH’s REsearching COVID to Enhance Recovery (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). 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 RelevanceRECOVER-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 Trials.gov IdentifierClinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011
Chang Linda、Jacoby Vanessa L.、Casey B.J.、Shakti Divya、Randall Isabelle G.、Tantisira Kelan G.、Atz Andrew M.、Aupperle Robin L.、Baskin-Sommers Arielle、Bind Marie-Abele C.、Buchbinder Natalie C.、Jacobus Joanna、Evans Danielle N.、Faustino E. Vincent S.、Fiks Alexander G.、Forsha Daniel、Foxe John J.、Wood Marion J.、Gallagher Richard、Gennaro Maria Laura、Katz Stuart D.、Kinser Patricia A.、Kleinman Lawrence C.、Lamendola-Essel Michelle F.、Salisbury Amy L.、Snowden Jessica N.、Stein Cheryl R.、Stockwell Melissa S.、Truong Dongngan T.、Ahmed Shifa、Akerlundh Almary、Alshawabkeh Akram N.、Gaur Sunanda、Hester Christina M.、Hill Sophia、Szmuszkovicz Jacqueline、Rosas Johana M.、Russell Mark W.、Sabati Arash A.、Sato Alice I.、Sharma Kavita、Bhuiyan Sultana、Clark Duncan B.、Clifton Rebecca G.、Cottrell Lesley、D?ˉSa Viren、Dehority Walter、Landeo-Gutierrez Jeremy、Lisdahl Krista M.、M¨1ller-Oehring Eva M.、Oliveira Carlos R.、Payne R. Mark、Raissy Hengameh、Rao Suchitra、Horowitz Carol R.、Hsia Daniel S.、Huentelman Matthew、Iacono William G.、Irby Katherine、Nahin Erica R.、Dasgupta Soham、Rosenzweig Erika B.、Flaherman Valerie J.、Wood John C.、Esquenazi-Karonika Shari、Heath Andrew C.、Thomason Moriah E.、Mohandas Sindhu、Werzberger Alan、Kasmarcak Tyler J.、Lang Sean M.、Lim Peter Paul C.、Fry Greta、B¨1k¨1lmez H¨1lya、Gray Kevin M.、Weyer Jordan C.、Kluko Matthew J.、Barch Deanna M.、Gee Dylan G.、Dreyer Benard P.、Bogie Amanda L.、Udosen Mmekom M.、Cicek Mine S.、Selvarangan Rangaraj、Rhee Kyung E.、Larson Christine L.、Zempsky William T.、Stevenson Michelle D.、Clouser Katharine N.、Teufel Ronald J. II、Sanil Yamuna、Dapretto Mirella、Aschner Judy L.、Dummer Kirsten B.、Warburton David、Neale Michael C.、Hobart-Porter Laura、Witvliet Margot Gage、Elias Matthew D.、Yin H. Shonna、Bueler Elliott、Oster Matthew E.、Morgan Lerraughn M.、Foulkes Andrea S.、Warner Megan R.、Mendelsohn Alan L.、Balaraman Venkataraman、Banerjee Dithi、Schechter Michael S.、Squeglia Lindsay M.、Thaweethai Tanayott、Hong Travis K.F.、Thacker Deepika、Laird Angela R.、Anderson Brett R.、McCulloh Russell J.、Ness-Cochinwala Manette、Baker Fiona C.、Newburger Jane W.、Hummel Kathy D.、Gross Rachel、Reeder Harrison T.、Metz Torri D.、Harahsheh Ashraf S.、Milner Joshua D.、Watson Sara E.、Karlson Elizabeth W.、McCrindle Brian W.、Nolan Sheila M.、Chibnik Lori B.、Heitzeg Mary M.、Talavera-Barber Maria M.、Jone Pei-Ni、Cowan Kelly、Elliott Amy J.、Friedman Naomi P.、Jernigan Terry L.、Chan James、Zimmerman Emily、Kosut Jessica S.、Mudumbi Praveen C.、Kaelber David C.
Department of Diagnostic Radiology and Nuclear Medicine, University of Maryland School of MedicineDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California San FranciscoDepartment of Neuroscience and Behavior, Barnard College - Columbia UniversityDepartment of Pediatrics, Pediatric Cardiology, University of Mississippi Medical CenterDepartment of Medicine, New York University Grossman School of MedicineDivision of Pediatric Respiratory Medicine, University of California San DiegoDepartment of Pediatrics, Medical University of South CarolinaOxley College of Health Sciences, Laureate Institute for Brain ResearchDepartment of Psychology, Yale UniversityDepartment of Biostatistics, Massachusetts General HospitalCenter for Human Development, University of California San DiegoDepartment of Psychiatry, University of California San DiegoArkansas Children?ˉs Research Institute, Arkansas Children?ˉs HospitalDepartment of Pediatrics, Yale School of MedicineDepartment of Pediatrics, Children?ˉs Hospital of PhiladelphiaDepartment of Cardiology, Children?ˉs Mercy Kansas City, Ward Family Heart CenterDepartment of Neuroscience, University of Rochester School of Medicine and DentistryDepartment of Population Health, New York University Grossman School of MedicineDepartment of Child and Adolescent Psychiatry, New York University Grossman School of MedicinePublic Health Research Institute and Department of Medicine, Rutgers New Jersey Medical SchoolDepartment of Medicine, New York University Grossman School of MedicineDepartment of Physical Medicine and Rehabilitation, Virginia Commonwealth University School of NursingDepartment of Pediatrics, Division of Population Health, Quality, and Implementation Sciences (POPQuIS), Rutgers Robert Wood Johnson Medical SchoolDepartment of Medicine, New York University Grossman School of MedicineSchool of Nursing, Virginia Commonwealth UniversityDepartments of Pediatrics and Biostatistics, University of Arkansas for Medical SciencesDepartment of Child and Adolescent Psychiatry, Hassenfeld Children?ˉs Hospital at NYU LangoneDepartment of Pediatrics, Division of Child and Adolescent Health, Columbia University Vagelos College of Physicians and Surgeons and NewYork-PresbyterianDivision of Pediatric Cardiology, University of Utah and Primary Children?ˉs HospitalDepartment of Biostatistics, Massachusetts General HospitalDepartment of Pulmonary Research, Rady Children?ˉs Hospital-San DiegoCollege of Engineering, Northeastern UniversityDepartment of Pediatrics, Rutgers Robert Wood Johnson Medical SchoolDivision of Practice-Based Research, Innovation, & Evaluation, American Academy of Family PhysiciansDepartment of Medicine, New York University Grossman School of MedicineDivision of Cardiology, Children?ˉs Hospital Los AngelesDepartment of Medicine, New York University Grossman School of MedicineDepartment of Pediatrics, University of Michigan Health SystemDepartment of Pediatric Cardiology, Phoenix Children?ˉs HospitalDepartment of Pediatric Infectious Disease, University of Nebraska Medical CenterDepartment of Pediatrics, University of Texas Southwestern Medical CenterDepartment of Medicine, New York University Grossman School of MedicineDepartments of Psychiatry and Pharmaceutical Sciences, University of PittsburghBiostatistics Center, George Washington UniversityDepartment of Pediatrics, West Virginia UniversityDepartment of Pediatrics, Rhode Island HospitalDepartment of Pediatrics, Division of Infectious Diseases, University of New MexicoDepartment of Pediatrics, Respiratory Medicine Division, University of California San DiegoDepartment of Psychology, University of Wisconsin-MilwaukeeCenter for Health Sciences, SRI InternationalDepartment of Pediatrics, Section of Infectious Diseases and Global Health, Yale University School of MedicineDepartment of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of MedicineDepartment of Pediatrics, University of New Mexico, Health Sciences CenterDepartment of Pediatrics, Division of Infectious Diseases, Epidemiology and Hospital Medicine, University of Colorado Anschutz Medical CampusCenter for Health Equity and Community Engaged Research and Department of Population Health Science and PolicyClinical Trials Unit, Pennington Biomedical Research CenterDivision of Neurogenomics, Translational Genomics Research InstituteDepartment of Psychology, University of Minnesota, MinneapolisDepartment of Pediatrics, Arkansas Children?ˉs Hospital, University of Arkansas Medical SchoolDepartment of Medicine, New York University Grossman School of MedicineDepartment of Pediatrics, Norton Children?ˉs Hospital, University of LouisvilleDepartment of Pediatrics, Columbia University Vagelos College of Physicians and SurgeonsDepartment of Pediatrics, University of California San FranciscoDepartment of Pediatrics and Radiology, Children?ˉs Hospital Los AngelesDepartment of Population Health, New York University Grossman School of MedicineDepartment of Psychiatry, Washington University School of MedicineDepartment of Child and Adolescent Psychiatry, New York University Grossman School of MedicineDepartment of Infectious Diseases, Children?ˉs Hospital Los Angeles and the Keck School of Medicine, University of Southern CaliforniaDepartment of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical CenterDepartment of Pediatric Clinical Research, Medical University of South CarolinaHeart Institute, Cincinnati Children?ˉs Hospital Medical CenterDepartment of Pediatric Infectious Disease, Avera McKennan University Health Center, University of South DakotaPennington Biomedical Research Center Clinic, Pennington Biomedical Research CenterDepartment of Pediatrics, Division of Rheumatology, The MetroHealth System, Case Western Reserve UniversityDepartment of Psychiatry and Behavioral Sciences, Medical University of South CarolinaCenter for Individualized Medicine, Mayo Clinic HospitalDepartment of Pediatrics, Yale School of MedicineDepartment of Psychological & Brain Sciences, Psychiatry, and Radiology, Washington University in St. Louis, Saint LouisDepartment of Psychology, Yale UniversityDepartment of Pediatrics, New York University Grossman School of MedicineDepartment of Pediatrics, University of Oklahoma Health Science CenterRECOVER Neurocognitive and Wellbeing/Mental Health Team, NYU Grossman School of MedicineDepartment of Laboratory Medicine and Pathology, Mayo Clinic HospitalDepartment of Pathology and Laboratory Medicine, Children?ˉs Mercy HospitalDepartment of Pediatrics, University of California San Diego School of MedicineDepartment of Psychology, University of Wisconsin-MilwaukeeDepartment of Pediatrics, Connecticut Children?ˉs Medical CenterDepartment of Pediatrics, University of Louisville School of MedicineDepartment of Pediatrics, Hackensack Meridian School of MedicineDepartment of Pediatrics, Medical University of South CarolinaDivision of Pediatric Cardiology, Children?ˉs Hospital of MichiganDepartment of Psychiatry and Biobehavioral Sciences, University of California Los AngelesDepartment of Pediatrics, Hackensack University Medical CenterDepartment of Pediatrics, University of California San DiegoDepartment of Pediatrics, Children?ˉs Hospital Los AngelesDepartment of Psychiatry, Virginia Commonwealth UniversityDepartments of Pediatrics and Physical Medicine & Rehabilitation, Section of Pediatric Rehabilitation, University of Arkansas for Medical SciencesDepartment of Sociology, Lamar UniversityDivision of Cardiology, Children?ˉs Hospital of PhiladelphiaDepartments of Pediatrics and Population Health, New York University Grossman School of MedicineDepartment of Medicine, New York University Grossman School of MedicineDepartment of Pediatric Cardiology, Children?ˉs Healthcare of AtlantaDepartment of Pediatrics, Valley Children?ˉs Healthcare, Department of PediatricsDepartment of Biostatistics, Massachusetts General HospitalDepartment of Pulmonary Research, Rady Children?ˉs Hospital-San DiegoDepartment of Pediatrics, Division of Developmental-Behavioral Pediatrics, New York University Grossman School of MedicineDepartment of Pediatrics, Kapiolani Medical Center for Women and ChildrenDepartment of Pathology and Laboratory Medicine, Children?ˉs Mercy HospitalDepartment of Pediatrics, Children?ˉs Hospital of Richmond at Virginia Commonwealth UniversityDepartment of Psychiatry and Behavioral Sciences, Medical University of South CarolinaDepartment of Biostatistics, Massachusetts General HospitalDepartment of Pediatrics, Kapiolani Medical Center for Women and ChildrenNemours Cardiac Center, Nemours Childrens Health, DelawareDepartment of Physics, Florida International UniversityDivision of Pediatric Cardiology, NewYork-Presbyterian/Columbia University Irving Medical CenterDepartment of Pediatrics, University of Nebraska Medical CenterDepartment of Pediatrics, Rutgers Robert Wood Johnson Medical SchoolCenter for Health Sciences, SRI InternationalDepartment of Cardiology, Boston Children?ˉs HospitalDepartment of Pediatrics, University of Arkansas for Medical SciencesDepartment of Pediatrics, New York University Grossman School of MedicineDepartment of Biostatistics, Massachusetts General HospitalDepartment of Obstetrics and Gynecology, University of Utah HealthDepartment of Pediatrics, Division of Cardiology, George Washington University School of Medicine & Health SciencesDepartment of Pediatrics, Columbia University Medical Center: Columbia University Irving Medical CenterDepartment of Pediatrics, University of Louisville School of MedicineDepartment of Medicine, Harvard Medical SchoolDepartment of Pediatrics, University of Toronto, Labatt Family Heart Center, The Hospital for Sick ChildrenDepartment of Pediatrics, New York Medical CollegeDepartment of Biostatistics, Massachusetts General HospitalDepartment of Psychiatry, University of MichiganDepartment of Pediatrics, Avera McKennan Hospital and University Health CenterDepartment of Pediatrics, Pediatric Cardiology, Lurie Children?ˉs Hospital, Northwestern University Feinberg School of MedicineDepartment of Pediatrics, Robert Larner M.D. College of Medicine at the University of VermontAvera Research Institute, Avera HealthInstitute for Behavioral Genetics and Department of Psychology and Neuroscience, University of Colorado BoulderCenter for Human Development, Cognitive Science, Psychiatry, Radiology, University of California San DiegoDepartment of Biostatistics, Massachusetts General HospitalDepartment of Communication Sciences & Disorders, Northeastern UniversityDepartment of Pediatrics, Kapiolani Medical Center for Women and ChildrenDepartment of Population Health, New York University Grossman School of MedicineDepartments of Pediatrics, Internal Medicine, and Population and Quantitative Health Sciences, Case Western Reserve University
医学研究方法儿科学医学现状、医学发展
Chang Linda,Jacoby Vanessa L.,Casey B.J.,Shakti Divya,Randall Isabelle G.,Tantisira Kelan G.,Atz Andrew M.,Aupperle Robin L.,Baskin-Sommers Arielle,Bind Marie-Abele C.,Buchbinder Natalie C.,Jacobus Joanna,Evans Danielle N.,Faustino E. Vincent S.,Fiks Alexander G.,Forsha Daniel,Foxe John J.,Wood Marion J.,Gallagher Richard,Gennaro Maria Laura,Katz Stuart D.,Kinser Patricia A.,Kleinman Lawrence C.,Lamendola-Essel Michelle F.,Salisbury Amy L.,Snowden Jessica N.,Stein Cheryl R.,Stockwell Melissa S.,Truong Dongngan T.,Ahmed Shifa,Akerlundh Almary,Alshawabkeh Akram N.,Gaur Sunanda,Hester Christina M.,Hill Sophia,Szmuszkovicz Jacqueline,Rosas Johana M.,Russell Mark W.,Sabati Arash A.,Sato Alice I.,Sharma Kavita,Bhuiyan Sultana,Clark Duncan B.,Clifton Rebecca G.,Cottrell Lesley,D?ˉSa Viren,Dehority Walter,Landeo-Gutierrez Jeremy,Lisdahl Krista M.,M¨1ller-Oehring Eva M.,Oliveira Carlos R.,Payne R. Mark,Raissy Hengameh,Rao Suchitra,Horowitz Carol R.,Hsia Daniel S.,Huentelman Matthew,Iacono William G.,Irby Katherine,Nahin Erica R.,Dasgupta Soham,Rosenzweig Erika B.,Flaherman Valerie J.,Wood John C.,Esquenazi-Karonika Shari,Heath Andrew C.,Thomason Moriah E.,Mohandas Sindhu,Werzberger Alan,Kasmarcak Tyler J.,Lang Sean M.,Lim Peter Paul C.,Fry Greta,B¨1k¨1lmez H¨1lya,Gray Kevin M.,Weyer Jordan C.,Kluko Matthew J.,Barch Deanna M.,Gee Dylan G.,Dreyer Benard P.,Bogie Amanda L.,Udosen Mmekom M.,Cicek Mine S.,Selvarangan Rangaraj,Rhee Kyung E.,Larson Christine L.,Zempsky William T.,Stevenson Michelle D.,Clouser Katharine N.,Teufel Ronald J. II,Sanil Yamuna,Dapretto Mirella,Aschner Judy L.,Dummer Kirsten B.,Warburton David,Neale Michael C.,Hobart-Porter Laura,Witvliet Margot Gage,Elias Matthew D.,Yin H. Shonna,Bueler Elliott,Oster Matthew E.,Morgan Lerraughn M.,Foulkes Andrea S.,Warner Megan R.,Mendelsohn Alan L.,Balaraman Venkataraman,Banerjee Dithi,Schechter Michael S.,Squeglia Lindsay M.,Thaweethai Tanayott,Hong Travis K.F.,Thacker Deepika,Laird Angela R.,Anderson Brett R.,McCulloh Russell J.,Ness-Cochinwala Manette,Baker Fiona C.,Newburger Jane W.,Hummel Kathy D.,Gross Rachel,Reeder Harrison T.,Metz Torri D.,Harahsheh Ashraf S.,Milner Joshua D.,Watson Sara E.,Karlson Elizabeth W.,McCrindle Brian W.,Nolan Sheila M.,Chibnik Lori B.,Heitzeg Mary M.,Talavera-Barber Maria M.,Jone Pei-Ni,Cowan Kelly,Elliott Amy J.,Friedman Naomi P.,Jernigan Terry L.,Chan James,Zimmerman Emily,Kosut Jessica S.,Mudumbi Praveen C.,Kaelber David C..Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design[EB/OL].(2025-03-28)[2025-05-28].https://www.medrxiv.org/content/10.1101/2023.04.27.23289228.点此复制
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