IU Indianapolis ScholarWorks :: Browsing by Author "Giuliano, John S., Jr."

Browsing by Author "Giuliano, John S., Jr."

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Changes in Distribution of Severe Neurologic Involvement in US Pediatric Inpatients With COVID-19 or Multisystem Inflammatory Syndrome in Children in 2021 vs 2020
(American Medical Association, 2023) LaRovere, Kerri L.; Poussaint, Tina Y.; Young, Cameron C.; Newhams, Margaret M.; Kucukak, Suden; Irby, Katherine; Kong, Michele; Schwartz, Stephanie P.; Walker, Tracie C.; Bembea, Melania M.; Wellnitz, Kari; Havlin, Kevin M.; Cvijanovich, Natalie Z.; Hall, Mark W.; Fitzgerald, Julie C.; Schuster, Jennifer E.; Hobbs, Charlotte V.; Halasa, Natasha B.; Singh, Aalok R.; Mack, Elizabeth H.; Bradford, Tamara T.; Gertz, Shira J.; Schwarz, Adam J.; Typpo, Katri V.; Loftis, Laura L.; Giuliano, John S., Jr.; Horwitz, Steven M.; Biagas, Katherine V.; Clouser, Katharine N.; Rowan, Courtney M.; Maddux, Aline B.; Soma, Vijaya L.; Babbitt, Christopher J.; Aguiar, Cassyanne L.; Kolmar, Amanda R.; Heidemann, Sabrina M.; Harvey, Helen; Zambrano, Laura D.; Campbell, Angela P.; Randolph, Adrienne G.; Overcoming COVID-19 Investigators; Pediatrics, School of Medicine
Importance: In 2020 during the COVID-19 pandemic, neurologic involvement was common in children and adolescents hospitalized in the United States for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related complications. Objective: To provide an update on the spectrum of SARS-CoV-2-related neurologic involvement among children and adolescents in 2021. Design, setting, and participants: Case series investigation of patients reported to public health surveillance hospitalized with SARS-CoV-2-related illness between December 15, 2020, and December 31, 2021, in 55 US hospitals in 31 states with follow-up at hospital discharge. A total of 2253 patients were enrolled during the investigation period. Patients suspected of having multisystem inflammatory syndrome in children (MIS-C) who did not meet criteria (n = 85) were excluded. Patients (<21 years) with positive SARS-CoV-2 test results (reverse transcriptase-polymerase chain reaction and/or antibody) meeting criteria for MIS-C or acute COVID-19 were included in the analysis. Exposure: SARS-CoV-2 infection. Main outcomes and measures: Patients with neurologic involvement had acute neurologic signs, symptoms, or diseases on presentation or during hospitalization. Life-threatening neurologic involvement was adjudicated by experts based on clinical and/or neuroradiological features. Type and severity of neurologic involvement, laboratory and imaging data, vaccination status, and hospital discharge outcomes (death or survival with new neurologic deficits). Results: Of 2168 patients included (58% male; median age, 10.3 years), 1435 (66%) met criteria for MIS-C, and 476 (22%) had documented neurologic involvement. Patients with neurologic involvement vs without were older (median age, 12 vs 10 years) and more frequently had underlying neurologic disorders (107 of 476 [22%] vs 240 of 1692 [14%]). Among those with neurologic involvement, 42 (9%) developed acute SARS-CoV-2-related life-threatening conditions, including central nervous system infection/demyelination (n = 23; 15 with possible/confirmed encephalitis, 6 meningitis, 1 transverse myelitis, 1 nonhemorrhagic leukoencephalopathy), stroke (n = 11), severe encephalopathy (n = 5), acute fulminant cerebral edema (n = 2), and Guillain-Barré syndrome (n = 1). Ten of 42 (24%) survived with new neurologic deficits at discharge and 8 (19%) died. Among patients with life-threatening neurologic conditions, 15 of 16 vaccine-eligible patients (94%) were unvaccinated. Conclusions and relevance: SARS-CoV-2-related neurologic involvement persisted in US children and adolescents hospitalized for COVID-19 or MIS-C in 2021 and was again mostly transient. Central nervous system infection/demyelination accounted for a higher proportion of life-threatening conditions, and most vaccine-eligible patients were unvaccinated. COVID-19 vaccination may prevent some SARS-CoV-2-related neurologic complications and merits further study.
Community-Onset Bacterial Coinfection in Children Critically Ill With Severe Acute Respiratory Syndrome Coronavirus 2 Infection
(Oxford University Press, 2023-03-06) Moffitt, Kristin L.; Nakamura, Mari M.; Young, Cameron C.; Newhams, Margaret M.; Halasa, Natasha B.; Reed, J. Nelson; Fitzgerald, Julie C.; Spinella, Philip C.; Soma, Vijaya L.; Walker, Tracie C.; Loftis, Laura L.; Maddux, Aline B.; Kong, Michele; Rowan, Courtney M.; Hobbs, Charlotte V.; Schuster, Jennifer E.; Riggs, Becky J.; McLaughlin, Gwenn E.; Michelson, Kelly N.; Hall, Mark W.; Babbitt, Christopher J.; Cvijanovich, Natalie Z.; Zinter, Matt S.; Maamari, Mia; Schwarz, Adam J.; Singh, Aalok R.; Flori, Heidi R.; Gertz, Shira J.; Staat, Mary A.; Giuliano, John S., Jr.; Hymes, Saul R.; Clouser, Katharine N.; McGuire, John; Carroll, Christopher L.; Thomas, Neal J.; Levy, Emily R.; Randolph, Adrienne G.; Pediatrics, School of Medicine
Background: Community-onset bacterial coinfection in adults hospitalized with coronavirus disease 2019 (COVID-19) is reportedly uncommon, though empiric antibiotic use has been high. However, data regarding empiric antibiotic use and bacterial coinfection in children with critical illness from COVID-19 are scarce. Methods: We evaluated children and adolescents aged <19 years admitted to a pediatric intensive care or high-acuity unit for COVID-19 between March and December 2020. Based on qualifying microbiology results from the first 3 days of admission, we adjudicated whether patients had community-onset bacterial coinfection. We compared demographic and clinical characteristics of those who did and did not (1) receive antibiotics and (2) have bacterial coinfection early in admission. Using Poisson regression models, we assessed factors associated with these outcomes. Results: Of the 532 patients, 63.3% received empiric antibiotics, but only 7.1% had bacterial coinfection, and only 3.0% had respiratory bacterial coinfection. In multivariable analyses, empiric antibiotics were more likely to be prescribed for immunocompromised patients (adjusted relative risk [aRR], 1.34 [95% confidence interval {CI}, 1.01-1.79]), those requiring any respiratory support except mechanical ventilation (aRR, 1.41 [95% CI, 1.05-1.90]), or those requiring invasive mechanical ventilation (aRR, 1.83 [95% CI, 1.36-2.47]) (compared with no respiratory support). The presence of a pulmonary comorbidity other than asthma (aRR, 2.31 [95% CI, 1.15-4.62]) was associated with bacterial coinfection. Conclusions: Community-onset bacterial coinfection in children with critical COVID-19 is infrequent, but empiric antibiotics are commonly prescribed. These findings inform antimicrobial use and support rapid de-escalation when evaluation shows coinfection is unlikely.
A Description of COVID-19-Directed Therapy in Children Admitted to US Intensive Care Units 2020
(Oxford University Press, 2022) Schuster, Jennifer E.; Halasa, Natasha B.; Nakamura, Mari; Levy, Emily R.; Fitzgerald, Julie C.; Young, Cameron C.; Newhams, Margaret M.; Bourgeois, Florence; Staat, Mary A.; Hobbs, Charlotte V.; Dapul, Heda; Feldstein, Leora R.; Jackson, Ashley M.; Mack, Elizabeth H.; Walker, Tracie C.; Maddux, Aline B.; Spinella, Philip C.; Loftis, Laura L.; Kong, Michele; Rowan, Courtney M.; Bembea, Melania M.; McLaughlin, Gwenn E.; Hall, Mark W.; Babbitt, Christopher J.; Maamari, Mia; Zinter, Matt S.; Cvijanovich, Natalie Z.; Michelson, Kelly N.; Gertz, Shira J.; Carroll, Christopher L.; Thomas, Neal J.; Giuliano, John S., Jr.; Singh, Aalok R.; Hymes, Saul R.; Schwarz, Adam J.; McGuire, John K.; Nofziger, Ryan A.; Flori, Heidi R.; Clouser, Katharine N.; Wellnitz, Kari; Cullimore, Melissa L.; Hume, Janet R.; Patel, Manish; Randolph, Adrienne G.; Overcoming COVID-19 Investigators; Pediatrics, School of Medicine
Background: It is unclear how acute coronavirus disease 2019 (COVID-19)-directed therapies are used in children with life-threatening COVID-19 in US hospitals. We described characteristics of children hospitalized in the intensive care unit or step-down unit (ICU/SDU) who received COVID-19-directed therapies and the specific therapies administered. Methods: Between March 15, 2020 and December 27, 2020, children <18 years of age in the ICU/SDU with acute COVID-19 at 48 pediatric hospitals in the United States were identified. Demographics, laboratory values, and clinical course were compared in children who did and did not receive COVID-19-directed therapies. Trends in COVID-19-directed therapies over time were evaluated. Results: Of 424 children in the ICU/SDU, 235 (55%) received COVID-19-directed therapies. Children who received COVID-19-directed therapies were older than those who did not receive COVID-19-directed therapies (13.3 [5.6-16.2] vs 9.8 [0.65-15.9] years), more had underlying medical conditions (188 [80%] vs 104 [55%]; difference = 25% [95% CI: 16% to 34%]), more received respiratory support (206 [88%] vs 71 [38%]; difference = 50% [95% CI: 34% to 56%]), and more died (8 [3.4%] vs 0). Of the 235 children receiving COVID-19-directed therapies, 172 (73%) received systemic steroids and 150 (64%) received remdesivir, with rising remdesivir use over the study period (14% in March/April to 57% November/December). Conclusion: Despite the lack of pediatric data evaluating treatments for COVID-19 in critically ill children, more than half of children requiring intensive or high acuity care received COVID-19-directed therapies.
Investigating Health Disparities Associated With Multisystem Inflammatory Syndrome in Children After SARS-CoV-2 Infection
(Wolters Kluwer, 2022) Zambrano, Laura D.; Ly, Kathleen N.; Link-Gelles, Ruth; Newhams, Margaret M.; Akande, Manzilat; Wu, Michael J.; Feldstein, Leora R.; Tarquinio, Keiko M.; Sahni, Leila C.; Riggs, Becky J.; Singh, Aalok R.; Fitzgerald, Julie C.; Schuster, Jennifer E.; Giuliano, John S., Jr.; Englund, Janet A.; Hume, Janet R.; Hall, Mark W.; Osborne, Christina M.; Doymaz, Sule; Rowan, Courtney M.; Babbitt, Christopher J.; Clouser, Katharine N.; Horwitz, Steven M.; Chou, Janet; Patel, Manish M.; Hobbs, Charlotte; Randolph, Adrienne G.; Campbell, Angela P.; Overcoming COVID-19 Investigators; Pediatrics, School of Medicine
Background: Multisystem inflammatory syndrome in children (MIS-C) is a postinfectious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related complication that has disproportionately affected racial/ethnic minority children. We conducted a pilot study to investigate risk factors for MIS-C aiming to understand MIS-C disparities. Methods: This case-control study included MIS-C cases and SARS-CoV-2-positive outpatient controls less than 18 years old frequency-matched 4:1 to cases by age group and site. Patients hospitalized with MIS-C were admitted between March 16 and October 2, 2020, across 17 pediatric hospitals. We evaluated race, ethnicity, social vulnerability index (SVI), insurance status, weight-for-age and underlying medical conditions as risk factors using mixed effects multivariable logistic regression. Results: We compared 241 MIS-C cases with 817 outpatient SARS-CoV-2-positive at-risk controls. Cases and controls had similar sex, age and U.S. census region distribution. MIS-C patients were more frequently previously healthy, non-Hispanic Black, residing in higher SVI areas, and in the 95th percentile or higher for weight-for-age. In the multivariable analysis, the likelihood of MIS-C was higher among non-Hispanic Black children [adjusted odds ratio (aOR): 2.07; 95% CI: 1.23-3.48]. Additionally, SVI in the 2nd and 3rd tertiles (aOR: 1.88; 95% CI: 1.18-2.97 and aOR: 2.03; 95% CI: 1.19-3.47, respectively) were independent factors along with being previously healthy (aOR: 1.64; 95% CI: 1.18-2.28). Conclusions: In this study, non-Hispanic Black children were more likely to develop MIS-C after adjustment for sociodemographic factors, underlying medical conditions, and weight-for-age. Investigation of the potential contribution of immunologic, environmental, and other factors is warranted.
Multisystem Inflammatory Syndrome in Children — Initial Therapy and Outcomes
(Massachusetts Medical Society, 2021-07-01) Son, Mary Beth F.; Murray, Nancy; Friedman, Kevin; Young, Cameron C.; Newhams, Margaret M.; Feldstein, Leora R.; Loftis, Laura L.; Tarquinio, Keiko M.; Singh, Aalok R.; Heidemann, Sabrina M.; Soma, Vijaya L.; Riggs, Becky J.; Fitzgerald, Julie C.; Kong, Michele; Doymaz, Sule; Giuliano, John S., Jr.; Keenaghan, Michael A.; Hume, Janet R.; Hobbs, Charlotte V.; Schuster, Jennifer E.; Clouser, Katharine N.; Hall, Mark W.; Smith, Lincoln S.; Horwitz, Steven M.; Schwartz, Stephanie P.; Irby, Katherine; Bradford, Tamara T.; Maddux, Aline B.; Babbitt, Christopher J.; Rowan, Courtney M.; McLaughlin, Gwenn E.; Yager, Phoebe H.; Maamari, Mia; Mack, Elizabeth H.; Carroll, Christopher L.; Montgomery, Vicki L.; Halasa, Natasha B.; Cvijanovich, Natalie Z.; Coates, Bria M.; Rose, Charles E.; Newburger, Jane W.; Patel, Manish M.; Randolph, Adrienne G.; Pediatrics, School of Medicine
Background: The assessment of real-world effectiveness of immunomodulatory medications for multisystem inflammatory syndrome in children (MIS-C) may guide therapy. Methods: We analyzed surveillance data on inpatients younger than 21 years of age who had MIS-C and were admitted to 1 of 58 U.S. hospitals between March 15 and October 31, 2020. The effectiveness of initial immunomodulatory therapy (day 0, indicating the first day any such therapy for MIS-C was given) with intravenous immune globulin (IVIG) plus glucocorticoids, as compared with IVIG alone, was evaluated with propensity-score matching and inverse probability weighting, with adjustment for baseline MIS-C severity and demographic characteristics. The primary outcome was cardiovascular dysfunction (a composite of left ventricular dysfunction or shock resulting in the use of vasopressors) on or after day 2. Secondary outcomes included the components of the primary outcome, the receipt of adjunctive treatment (glucocorticoids in patients not already receiving glucocorticoids on day 0, a biologic, or a second dose of IVIG) on or after day 1, and persistent or recurrent fever on or after day 2. Results: A total of 518 patients with MIS-C (median age, 8.7 years) received at least one immunomodulatory therapy; 75% had been previously healthy, and 9 died. In the propensity-score-matched analysis, initial treatment with IVIG plus glucocorticoids (103 patients) was associated with a lower risk of cardiovascular dysfunction on or after day 2 than IVIG alone (103 patients) (17% vs. 31%; risk ratio, 0.56; 95% confidence interval [CI], 0.34 to 0.94). The risks of the components of the composite outcome were also lower among those who received IVIG plus glucocorticoids: left ventricular dysfunction occurred in 8% and 17% of the patients, respectively (risk ratio, 0.46; 95% CI, 0.19 to 1.15), and shock resulting in vasopressor use in 13% and 24% (risk ratio, 0.54; 95% CI, 0.29 to 1.00). The use of adjunctive therapy was lower among patients who received IVIG plus glucocorticoids than among those who received IVIG alone (34% vs. 70%; risk ratio, 0.49; 95% CI, 0.36 to 0.65), but the risk of fever was unaffected (31% and 40%, respectively; risk ratio, 0.78; 95% CI, 0.53 to 1.13). The inverse-probability-weighted analysis confirmed the results of the propensity-score-matched analysis. Conclusions: Among children and adolescents with MIS-C, initial treatment with IVIG plus glucocorticoids was associated with a lower risk of new or persistent cardiovascular dysfunction than IVIG alone. (Funded by the Centers for Disease Control and Prevention.).

Browsing by Author "Giuliano, John S., Jr."

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