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Characterizing Long COVID Symptoms During Early Childhood

Gross, Rachel S.; Thaweethai, Tanayott; Salisbury, Amy L.; Kleinman, Lawrence C.; Mohandas, Sindhu; Rhee, Kyung E.; Snowden, Jessica N.; Tantisira, Kelan G.; Warburton, David; Wood, John C.; Kinser, Patricia A.; Milner, Joshua D.; Rosenzweig, Erika B.; Irby, Katherine; Flaherman, Valerie J.; Karlson, Elizabeth W.; Chibnik, Lori B.; Pant, Deepti B.; Krishnamoorthy, Aparna; Gallagher, Richard; Lamendola-Essel, Michelle F.; Hasson, Denise C.; Katz, Stuart D.; Yin, Shonna; Dreyer, Benard P.; Blancero, Frank; Carmilani, Megan; Coombs, K.; Fitzgerald, Megan L.; Letts, Rebecca J.; Peddie, Aimee K.; Foulkes, Andrea S.; Stockwell, Melissa S.; RECOVER Pediatrics Group Authors; RECOVER Pediatrics Consortium
ORIGINAL:0017675
ISSN: 2168-6203
CID: 5853942

Characterizing Long COVID Symptoms During Early Childhood

Gross, Rachel S; Thaweethai, Tanayott; Salisbury, Amy L; Kleinman, Lawrence C; Mohandas, Sindhu; Rhee, Kyung E; Snowden, Jessica N; Tantisira, Kelan G; Warburton, David; Wood, John C; Kinser, Patricia A; Milner, Joshua D; Rosenzweig, Erika B; Irby, Katherine; Flaherman, Valerie J; Karlson, Elizabeth W; Chibnik, Lori B; Pant, Deepti B; Krishnamoorthy, Aparna; Gallagher, Richard; Lamendola-Essel, Michelle F; Hasson, Denise C; Katz, Stuart D; Yin, Shonna; Dreyer, Benard P; Blancero, Frank; Carmilani, Megan; Coombs, K; Fitzgerald, Megan L; Letts, Rebecca J; Peddie, Aimee K; Aschner, Judy L; Atz, Andrew M; Banerjee, Dithi; Bogie, Amanda; Bukulmez, Hulya; Clouser, Katharine; Cottrell, Lesley A; Cowan, Kelly; D'Sa, Viren A; Dozor, Allen; Elliott, Amy J; Faustino, E Vincent S; Fiks, Alexander G; Gaur, Sunanda; Gennaro, Maria L; Gordon, Stewart; Hasan, Uzma N; Hester, Christina M; Hogan, Alexander; Hsia, Daniel S; Kaelber, David C; Kosut, Jessica S; Krishnan, Sankaran; McCulloh, Russell J; Michelow, Ian C; Nolan, Sheila M; Oliveira, Carlos R; Olson, Lynn M; Pace, Wilson D; Palumbo, Paul; Raissy, Hengameh; Reyes, Andy; Ross, Judith L; Salazar, Juan C; Selvarangan, Rangaraj; Stein, Cheryl R; Stevenson, Michelle D; Teufel, Ronald J; Werzberger, Alan; Westfall, John M; Zani, Kathleen; Zempsky, William T; Zimmerman, Emily; Bind, Marie-Abele C; Chan, James; Guan, Zoe; Morse, Richard E; Reeder, Harrison T; Metz, Torri D; Newburger, Jane W; Truong, Dongngan T; Foulkes, Andrea S; Stockwell, Melissa S; ,; ,
IMPORTANCE:Recent studies have identified characteristic symptom patterns of long COVID (LC) in adults and children older than 5 years. However, LC remains poorly characterized in early childhood. This knowledge gap limits efforts to identify, care for, and prevent LC in this vulnerable population. OBJECTIVES:To identify symptoms that had the greatest difference in frequency comparing children with a history of SARS-CoV-2 infection to those without, to identify differences in the types of symptoms by age group (infants/toddlers [0-2 years] vs preschool-aged children [3-5 years]), and to derive an index that can be used in research studies to identify young children with LC. DESIGN, SETTING, AND PARTICIPANTS:This was a multisite longitudinal cohort study with enrollment from over 30 US health care and community settings, including infants, toddlers, and preschool-aged children with and without SARS-CoV-2 infection history. Study data were analyzed from May to December 2024. EXPOSURE:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES:LC and 41 symptoms among infants/toddlers and 75 symptoms among preschool-aged children. RESULTS:The study included 472 infants/toddlers (mean [SD] age, 12 [9] months; 278 infected with SARS-CoV-2; 194 uninfected; 234 male [50%]; 73 Black or African American [16%]; 198 Hispanic, Latino, or Spanish [43%]; 242 White [52%]) and 539 preschool-aged children (mean [SD] age, 48 [10] months; 399 infected with SARS-CoV-2; 140 uninfected; 277 female [51%]; 70 Black or African American [13%]; 210 Hispanic, Latino, or Spanish [39%]; 287 White [54%]). The median (IQR) time between first infections and completion of symptom surveys was 318 (198-494) days for infants/toddlers and 520 (330-844) days for preschool-aged children. A research index was derived for each age group based on symptoms most associated with infection history. The index is calculated by summing scores assigned to each prolonged symptom that was present, where higher scores indicate greater magnitude of association with history of SARS-CoV-2 infection: poor appetite (5 points), trouble sleeping (3.5 points), wet cough (3.5 points), dry cough (3 points), and stuffy nose (0.5 points) for infants/toddlers, and daytime tiredness/sleepiness/low energy (6.5 points) and dry cough (3 points) for preschool-aged children. Among infants/toddlers with infection, 40 of 278 (14%) were classified as having probable LC by having an index of at least 4 points. Among preschool-aged children, 61 of 399 (15%) were classified as having probable LC by having an index of at least 3 points. Participants with higher indices often had poorer overall health, lower quality of life, and perceived delays in developmental milestones. CONCLUSIONS AND RELEVANCE:This cohort study identified symptom patterns and derived research indices that were distinct between the 2 age groups and differed from those previously identified in older ages, demonstrating the need to characterize LC separately across age ranges.
PMID: 40554463
ISSN: 2168-6211
CID: 5911972

Caring for Patients Seeking Asylum: Early Data From the Safety Net System in New York City

Newton-Dame, Remle; Jacobson, Laura; Wallach, Andrew B; Silverman, Erica; Dreyer, Benard; Long, Theodore
CONTEXT/BACKGROUND:Over 200 000 people seeking asylum have arrived in New York City from 2022 to 2024. PROGRAM/METHODS:As the safety net hospital system for our city, New York City (NYC) Health + Hospitals (H + H) has taken the lead in caring for newly arrived asylum seekers. We used electronic medical record data to gain early insights into utilization and needs among these patients. IMPLEMENTATION/METHODS:We developed a hybrid definition to identify patients who are asylum seekers and examined their demographics, insurance, utilization, primary billing diagnoses, and immunizations from the Epic EMR. We included data on other patients as a point of comparison and analyzed data separately for adult and pediatric patients. EVALUATION/RESULTS:In 2023, 15 233 or 1.4% of H + H patients were asylum seekers. Asylum seekers had fewer visits than other patients in 2023, and utilization was particularly driven by pregnancy and childbirth. Children seeking asylum were engaged in primary care at high rates. Documented childhood vaccinations were higher among asylum-seeking children engaged in primary care compared to those who were not. The majority of adults and children were insured. Adult primary care engagement was low, as were visits for those seeking care for behavioral health issues. DISCUSSION/CONCLUSIONS:For adult asylum seekers, pregnancy and childbirth are key needs for adults. Increasing vaccination rates among children is critical and promoting engagement in primary care is a promising way to do so. Coordinated efforts are required to meet the varied needs of migrant arrivals, and safety net hospitals can play a key role in addressing their health care needs.
PMID: 39724081
ISSN: 1550-5022
CID: 5767672

The 2024 Joseph W. St. Geme, Jr Leadership Award Address: To Create a Better World for Children and Families

Dreyer, Benard P
PMID: 39439430
ISSN: 1098-4275
CID: 5739872

Characterizing Long COVID in Children and Adolescents

Gross, Rachel S; Thaweethai, Tanayott; Kleinman, Lawrence C; Snowden, Jessica N; Rosenzweig, Erika B; Milner, Joshua D; Tantisira, Kelan G; Rhee, Kyung E; Jernigan, Terry L; Kinser, Patricia A; Salisbury, Amy L; Warburton, David; Mohandas, Sindhu; Wood, John C; Newburger, Jane W; Truong, Dongngan T; Flaherman, Valerie J; Metz, Torri D; Karlson, Elizabeth W; Chibnik, Lori B; Pant, Deepti B; Krishnamoorthy, Aparna; Gallagher, Richard; Lamendola-Essel, Michelle F; Hasson, Denise C; Katz, Stuart D; Yin, Shonna; Dreyer, Benard P; Carmilani, Megan; Coombs, K; Fitzgerald, Megan L; Güthe, Nick; Hornig, Mady; Letts, Rebecca J; Peddie, Aimee K; Taylor, Brittany D; Foulkes, Andrea S; Stockwell, Melissa S; ,; ,; Balaraman, Venkataraman; Bogie, Amanda; Bukulmez, Hulya; Dozor, Allen J; Eckrich, Daniel; Elliott, Amy J; Evans, Danielle N; Farkas, Jonathan S; Faustino, E Vincent S; Fischer, Laura; Gaur, Sunanda; Harahsheh, Ashraf S; Hasan, Uzma N; Hsia, Daniel S; Huerta-Montañez, Gredia; Hummel, Kathy D; Kadish, Matt P; Kaelber, David C; Krishnan, Sankaran; Kosut, Jessica S; Larrabee, Jerry; Lim, Peter Paul C; Michelow, Ian C; Oliveira, Carlos R; Raissy, Hengameh; Rosario-Pabon, Zaira; Ross, Judith L; Sato, Alice I; Stevenson, Michelle D; Talavera-Barber, Maria M; Teufel, Ronald J; Weakley, Kathryn E; Zimmerman, Emily; Bind, Marie-Abele C; Chan, James; Guan, Zoe; Morse, Richard E; Reeder, Harrison T; Akshoomoff, Natascha; Aschner, Judy L; Bhattacharjee, Rakesh; Cottrell, Lesley A; Cowan, Kelly; D'Sa, Viren A; Fiks, Alexander G; Gennaro, Maria L; Irby, Katherine; Khare, Manaswitha; Guttierrez, Jeremy Landeo; McCulloh, Russell J; Narang, Shalu; Ness-Cochinwala, Manette; Nolan, Sheila; Palumbo, Paul; Ryu, Julie; Salazar, Juan C; Selvarangan, Rangaraj; Stein, Cheryl R; Werzberger, Alan; Zempsky, William T; Aupperle, Robin; Baker, Fiona C; Banich, Marie T; Barch, Deanna M; Baskin-Sommers, Arielle; Bjork, James M; Bookheimer, Susan Y; Brown, Sandra A; Casey, B J; Chang, Linda; Clark, Duncan B; Dale, Anders M; Dapretto, Mirella; Ernst, Thomas M; Fair, Damien A; Feldstein Ewing, Sarah W; Foxe, John J; Freedman, Edward G; Friedman, Naomi P; Garavan, Hugh; Gee, Dylan G; Gonzalez, Raul; Gray, Kevin M; Heitzeg, Mary M; Herting, Megan M; Jacobus, Joanna; Laird, Angela R; Larson, Christine L; Lisdahl, Krista M; Luciana, Monica; Luna, Beatriz; Madden, Pamela A F; McGlade, Erin C; Müller-Oehring, Eva M; Nagel, Bonnie J; Neale, Michael C; Paulus, Martin P; Potter, Alexandra S; Renshaw, Perry F; Sowell, Elizabeth R; Squeglia, Lindsay M; Tapert, Susan; Uddin, Lucina Q; Wilson, Sylia; Yurgelun-Todd, Deborah A
IMPORTANCE/UNASSIGNED:Most research to understand postacute sequelae of SARS-CoV-2 infection (PASC), or long COVID, has focused on adults, with less known about this complex condition in children. Research is needed to characterize pediatric PASC to enable studies of underlying mechanisms that will guide future treatment. OBJECTIVE/UNASSIGNED:To identify the most common prolonged symptoms experienced by children (aged 6 to 17 years) after SARS-CoV-2 infection, how these symptoms differ by age (school-age [6-11 years] vs adolescents [12-17 years]), how they cluster into distinct phenotypes, and what symptoms in combination could be used as an empirically derived index to assist researchers to study the likely presence of PASC. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Multicenter longitudinal observational cohort study with participants recruited from more than 60 US health care and community settings between March 2022 and December 2023, including school-age children and adolescents with and without SARS-CoV-2 infection history. EXPOSURE/UNASSIGNED:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES/UNASSIGNED:PASC and 89 prolonged symptoms across 9 symptom domains. RESULTS/UNASSIGNED:A total of 898 school-age children (751 with previous SARS-CoV-2 infection [referred to as infected] and 147 without [referred to as uninfected]; mean age, 8.6 years; 49% female; 11% were Black or African American, 34% were Hispanic, Latino, or Spanish, and 60% were White) and 4469 adolescents (3109 infected and 1360 uninfected; mean age, 14.8 years; 48% female; 13% were Black or African American, 21% were Hispanic, Latino, or Spanish, and 73% were White) were included. Median time between first infection and symptom survey was 506 days for school-age children and 556 days for adolescents. In models adjusted for sex and race and ethnicity, 14 symptoms in both school-age children and adolescents were more common in those with SARS-CoV-2 infection history compared with those without infection history, with 4 additional symptoms in school-age children only and 3 in adolescents only. These symptoms affected almost every organ system. Combinations of symptoms most associated with infection history were identified to form a PASC research index for each age group; these indices correlated with poorer overall health and quality of life. The index emphasizes neurocognitive, pain, and gastrointestinal symptoms in school-age children but change or loss in smell or taste, pain, and fatigue/malaise-related symptoms in adolescents. Clustering analyses identified 4 PASC symptom phenotypes in school-age children and 3 in adolescents. CONCLUSIONS AND RELEVANCE/UNASSIGNED:This study developed research indices for characterizing PASC in children and adolescents. Symptom patterns were similar but distinguishable between the 2 groups, highlighting the importance of characterizing PASC separately for these age ranges.
PMID: 39196964
ISSN: 1538-3598
CID: 5686502

Postacute Sequelae of SARS-CoV-2 in Children

Rao, Suchitra; Gross, Rachel S; Mohandas, Sindhu; Stein, Cheryl R; Case, Abigail; Dreyer, Benard; Pajor, Nathan M; Bunnell, H Timothy; Warburton, David; Berg, Elizabeth; Overdevest, Jonathan B; Gorelik, Mark; Milner, Joshua; Saxena, Sejal; Jhaveri, Ravi; Wood, John C; Rhee, Kyung E; Letts, Rebecca; Maughan, Christine; Guthe, Nick; Castro-Baucom, Leah; Stockwell, Melissa S
The coronavirus disease 2019 (COVID-19) pandemic has caused significant medical, social, and economic impacts globally, both in the short and long term. Although most individuals recover within a few days or weeks from an acute infection, some experience longer lasting effects. Data regarding the postacute sequelae of severe acute respiratory syndrome coronavirus 2 infection (PASC) in children, or long COVID, are only just emerging in the literature. These symptoms and conditions may reflect persistent symptoms from acute infection (eg, cough, headaches, fatigue, and loss of taste and smell), new symptoms like dizziness, or exacerbation of underlying conditions. Children may develop conditions de novo, including postural orthostatic tachycardia syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, autoimmune conditions and multisystem inflammatory syndrome in children. This state-of-the-art narrative review provides a summary of our current knowledge about PASC in children, including prevalence, epidemiology, risk factors, clinical characteristics, underlying mechanisms, and functional outcomes, as well as a conceptual framework for PASC based on the current National Institutes of Health definition. We highlight the pediatric components of the National Institutes of Health-funded Researching COVID to Enhance Recovery Initiative, which seeks to characterize the natural history, mechanisms, and long-term health effects of PASC in children and young adults to inform future treatment and prevention efforts. These initiatives include electronic health record cohorts, which offer rapid assessments at scale with geographical and demographic diversity, as well as longitudinal prospective observational cohorts, to estimate disease burden, illness trajectory, pathobiology, and clinical manifestations and outcomes.
PMID: 38321938
ISSN: 1098-4275
CID: 5632602

Promotion of Positive Childhood Experiences and Early Relational Health in Pediatric Primary Care: Accumulating Evidence

Roby, Erin; Canfield, Caitlin F; Seery, Anne M; Dreyer, Benard; Mendelsohn, Alan L
PMCID:10939971
PMID: 37748538
ISSN: 1876-2867
CID: 5645552

Implementing a Family-Centered Rounds Intervention Using Novel Mentor-Trios

Khan, Alisa; Patel, Shilpa J; Anderson, Michele; Baird, Jennifer D; Johnson, Tyler M; Liss, Isabella; Graham, Dionne A; Calaman, Sharon; Fegley, April E; Goldstein, Jenna; O'Toole, Jennifer K; Rosenbluth, Glenn; Alminde, Claire; Bass, Ellen J; Bismilla, Zia; Caruth, Monique; Coghlan-McDonald, Sally; Cray, Sharon; Destino, Lauren A; Dreyer, Benard P; Everhart, Jennifer L; Good, Brian P; Guiot, Amy B; Haskell, Helen; Hepps, Jennifer H; Knighton, Andrew J; Kocolas, Irene; Kuzma, Nicholas C; Lewis, Kheyandra; Litterer, Katherine P; Kruvand, Elizabeth; Markle, Peggy; Micalizzi, Dale A; Patel, Aarti; Rogers, Jayne E; Subramony, Anupama; Vara, Tiffany; Yin, H Shonna; Sectish, Theodore C; Srivastava, Rajendu; Starmer, Amy J; West, Daniel C; Spector, Nancy D; Landrigan, Christopher P; ,
BACKGROUND AND OBJECTIVES/OBJECTIVE:Patient and Family Centered I-PASS (PFC I-PASS) emphasizes family and nurse engagement, health literacy, and structured communication on family-centered rounds organized around the I-PASS framework (Illness severity-Patient summary-Action items-Situational awareness-Synthesis by receiver). We assessed adherence, safety, and experience after implementing PFC I-PASS using a novel "Mentor-Trio" implementation approach with multidisciplinary parent-nurse-physician teams coaching sites. METHODS:Hybrid Type II effectiveness-implementation study from 2/29/19-3/13/22 with ≥3 months of baseline and 12 months of postimplementation data collection/site across 21 US community and tertiary pediatric teaching hospitals. We conducted rounds observations and surveyed nurses, physicians, and Arabic/Chinese/English/Spanish-speaking patients/parents. RESULTS:We conducted 4557 rounds observations and received 2285 patient/family, 1240 resident, 819 nurse, and 378 attending surveys. Adherence to all I-PASS components, bedside rounding, written rounds summaries, family and nurse engagement, and plain language improved post-implementation (13.0%-60.8% absolute increase by item), all P < .05. Except for written summary, improvements sustained 12 months post-implementation. Resident-reported harms/1000-resident-days were unchanged overall but decreased in larger hospitals (116.9 to 86.3 to 72.3 pre versus early- versus late-implementation, P = .006), hospitals with greater nurse engagement on rounds (110.6 to 73.3 to 65.3, P < .001), and greater adherence to I-PASS structure (95.3 to 73.6 to 72.3, P < .05). Twelve of 12 measures of staff safety climate improved (eg, "excellent"/"very good" safety grade improved from 80.4% to 86.3% to 88.0%), all P < .05. Patient/family experience and teaching were unchanged. CONCLUSIONS:Hospitals successfully used Mentor-Trios to implement PFC I-PASS. Family/nurse engagement, safety climate, and harms improved in larger hospitals and hospitals with better nurse engagement and intervention adherence. Patient/family experience and teaching were not affected.
PMID: 38164122
ISSN: 1098-4275
CID: 5627932

Racism and Pediatrics: Finding a Way Forward to Advance Child Health

Raphael, Jean L; Dreyer, Benard P; Szilagyi, Peter G; Trent, Maria E
PMID: 39428141
ISSN: 1876-2867
CID: 5739422

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

Gross, Rachel S; Thaweethai, Tanayott; Rosenzweig, Erika B; Chan, James; Chibnik, Lori B; Cicek, Mine S; Elliott, Amy J; Flaherman, Valerie J; Foulkes, Andrea S; Gage Witvliet, Margot; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L; Karlson, Elizabeth W; Katz, Stuart D; Kinser, Patricia A; Kleinman, Lawrence C; Lamendola-Essel, Michelle F; Milner, Joshua D; Mohandas, Sindhu; Mudumbi, Praveen C; Newburger, Jane W; Rhee, Kyung E; Salisbury, Amy L; Snowden, Jessica N; Stein, Cheryl R; Stockwell, Melissa S; Tantisira, Kelan G; Thomason, Moriah E; Truong, Dongngan T; Warburton, David; Wood, John C; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N; Anderson, Brett R; Aschner, Judy L; Atz, Andrew M; Aupperle, Robin L; Baker, Fiona C; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C; Bogie, Amanda L; Bradford, Tamara; Buchbinder, Natalie C; Bueler, Elliott; Bükülmez, Hülya; Casey, B J; Chang, Linda; Chrisant, Maryanne; Clark, Duncan B; Clifton, Rebecca G; Clouser, Katharine N; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dionne, Audrey; Dummer, Kirsten B; Elias, Matthew D; Esquenazi-Karonika, Shari; Evans, Danielle N; Faustino, E Vincent S; Fiks, Alexander G; Forsha, Daniel; Foxe, John J; Friedman, Naomi P; Fry, Greta; Gaur, Sunanda; Gee, Dylan G; Gray, Kevin M; Handler, Stephanie; Harahsheh, Ashraf S; Hasbani, Keren; Heath, Andrew C; Hebson, Camden; Heitzeg, Mary M; Hester, Christina M; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K F; Horowitz, Carol R; Hsia, Daniel S; Huentelman, Matthew; Hummel, Kathy D; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L; Jone, Pei-Ni; Kaelber, David C; Kasmarcak, Tyler J; Kluko, Matthew J; Kosut, Jessica S; Laird, Angela R; Landeo-Gutierrez, Jeremy; Lang, Sean M; Larson, Christine L; Lim, Peter Paul C; Lisdahl, Krista M; McCrindle, Brian W; McCulloh, Russell J; McHugh, Kimberly; Mendelsohn, Alan L; Metz, Torri D; Miller, Julie; Mitchell, Elizabeth C; Morgan, Lerraughn M; Müller-Oehring, Eva M; Nahin, Erica R; Neale, Michael C; Ness-Cochinwala, Manette; Nolan, Sheila M; Oliveira, Carlos R; Osakwe, Onyekachukwu; Oster, Matthew E; Payne, R Mark; Portman, Michael A; Raissy, Hengameh; Randall, Isabelle G; Rao, Suchitra; Reeder, Harrison T; Rosas, Johana M; Russell, Mark W; Sabati, Arash A; Sanil, Yamuna; Sato, Alice I; Schechter, Michael S; Selvarangan, Rangaraj; Sexson Tejtel, S Kristen; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M; Srivastava, Shubika; Stevenson, Michelle D; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M; Teufel, Ronald J; Thacker, Deepika; Trachtenberg, Felicia; Udosen, Mmekom M; Warner, Megan R; Watson, Sara E; Werzberger, Alan; Weyer, Jordan C; Wood, Marion J; Yin, H Shonna; Zempsky, William T; Zimmerman, Emily; Dreyer, Benard P; ,
IMPORTANCE/OBJECTIVE: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/METHODS:We 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 four 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/CONCLUSIONS: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 TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
PMCID:11075869
PMID: 38713673
ISSN: 1932-6203
CID: 5658342