1,112 results on '"Thomas, Neal J."'
Search Results
202. Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.
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UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Michelson, Kelly N, Reubenson, Gary, Weiss, Scott L, Fitzgerald, Julie C, Ackerman, Kate K, Christie, LeeAnn, Bush, Jenny L, Nadkarni, Vinay M, Thomas, Neal J, Schreiner, Mark S, Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators, Pediatric Acute Lung Injury and Sepsis Investigators Network, Clément de Cléty, Stéphan, Dujardin Marie-France, Berghe, Caroline, Renard, Suzanne, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Michelson, Kelly N, Reubenson, Gary, Weiss, Scott L, Fitzgerald, Julie C, Ackerman, Kate K, Christie, LeeAnn, Bush, Jenny L, Nadkarni, Vinay M, Thomas, Neal J, Schreiner, Mark S, Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators, Pediatric Acute Lung Injury and Sepsis Investigators Network, Clément de Cléty, Stéphan, Dujardin Marie-France, Berghe, Caroline, and Renard, Suzanne
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OBJECTIVES: Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. DESIGN: Survey. SETTING: Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. SUBJECTS: Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional
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- 2018
203. The Association of Nutrition Status Expressed as Body Mass Index z Score With Outcomes in Children With Severe Sepsis: A Secondary Analysis From the Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study.
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UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Irving, Sharon Y, Daly, Bridget, Verger, Judy, Typpo, Katri V, Brown, Ann-Marie, Hanlon, Alexandra, Weiss, Scott L, Fitzgerald, Julie C, Nadkarni, Vinay M, Thomas, Neal J, Srinivasan, Vijay, Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, Clément de Cléty, Stéphan, Dujardin, Marie-France, Berghe, Caroline, Renard, Suzanne, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Irving, Sharon Y, Daly, Bridget, Verger, Judy, Typpo, Katri V, Brown, Ann-Marie, Hanlon, Alexandra, Weiss, Scott L, Fitzgerald, Julie C, Nadkarni, Vinay M, Thomas, Neal J, Srinivasan, Vijay, Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, Clément de Cléty, Stéphan, Dujardin, Marie-France, Berghe, Caroline, and Renard, Suzanne
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OBJECTIVES: The impact of nutrition status on outcomes in pediatric severe sepsis is unclear. We studied the association of nutrition status (expressed as body mass index z score) with outcomes in pediatric severe sepsis. DESIGN: Secondary analysis of the Sepsis Prevalence, Outcomes, and Therapies study. Patient characteristics, ICU interventions, and outcomes were compared across nutrition status categories (expressed as age- and sex-adjusted body mass index z scores using World Health Organization standards). Multivariable regression models were developed to determine adjusted differences in all-cause ICU mortality and ICU length of stay by nutrition status. SETTING: One-hundred twenty-eight PICUs across 26 countries. PATIENTS: Children less than 18 years with severe sepsis enrolled in the Sepsis Prevalence, Outcomes, and Therapies study (n = 567). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Nutrition status data were available for 417 patients. Severe undernutrition was seen in Europe (25%), Asia (20%), South Africa (17%), and South America (10%), with severe overnutrition seen in Australia/New Zealand (17%) and North America (14%). Severe undernutrition was independently associated with all-cause ICU mortality (adjusted odds ratio, 3.0; 95% CI, 1.2-7.7; p = 0.02), whereas severe overnutrition in survivors was independently associated with longer ICU length of stay (1.6 d; p = 0.01). CONCLUSIONS: There is considerable variation in nutrition status for children with severe sepsis treated across this selected network of PICUs from different geographic regions. Severe undernutrition was independently associated with higher all-cause ICU mortality in children with severe sepsis. Severe overnutrition was independently associated with greater ICU length of stay in childhood survivors of severe sepsis.
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- 2018
204. A Culture Independent Method for Rapid Detection of Bacteria in Pediatric Blood
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Karunathilake, Eranda, Umstead, Todd, Spear, Debbie, E. Scott Haltead, Chroneos, Zissis C., and Thomas, Neal J.
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- 2017
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205. CALIPSO: A Randomized Controlled Trial of Calfactant for Acute Lung Injury in Pediatric Stem Cell and Oncology Patients
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Thomas, Neal J., primary, Spear, Debbie, additional, Wasserman, Emily, additional, Pon, Steven, additional, Markovitz, Barry, additional, Singh, Aalok R., additional, Li, Simon, additional, Gertz, Shira J., additional, Rowan, Courtney M., additional, Kunselman, Allen, additional, and Tamburro, Robert F., additional
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- 2018
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206. The Association of Nutrition Status Expressed as Body Mass Index z Score With Outcomes in Children With Severe Sepsis: A Secondary Analysis From the Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study*
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Irving, Sharon Y., primary, Daly, Bridget, additional, Verger, Judy, additional, Typpo, Katri V., additional, Brown, Ann-Marie, additional, Hanlon, Alexandra, additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Nadkarni, Vinay M., additional, Thomas, Neal J., additional, and Srinivasan, Vijay, additional
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- 2018
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207. New Morbidity and Discharge Disposition of Pediatric Acute Respiratory Distress Syndrome Survivors*
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Keim, Garrett, primary, Watson, R. Scott, additional, Thomas, Neal J., additional, and Yehya, Nadir, additional
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- 2018
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208. Epidemiology of Cause of Death in Pediatric Acute Respiratory Distress Syndrome
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Dowell, Jasmine C., primary, Parvathaneni, Kaushik, additional, Thomas, Neal J., additional, Khemani, Robinder G., additional, and Yehya, Nadir, additional
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- 2018
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209. Genetic Association of Pulmonary Surfactant Protein Genes, SFTPA1, SFTPA2, SFTPB, SFTPC, and SFTPD With Cystic Fibrosis
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Lin, Zhenwu, primary, Thorenoor, Nithyananda, additional, Wu, Rongling, additional, DiAngelo, Susan L., additional, Ye, Meixia, additional, Thomas, Neal J., additional, Liao, Xiaojie, additional, Lin, Tony R., additional, Warren, Stuart, additional, and Floros, Joanna, additional
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- 2018
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210. Reply to Tremlett and Kanthimathinathan and to Koopman and Kneyber
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Khemani, Robinder G., primary, Parvathaneni, Kaushik, additional, Yehya, Nadir, additional, Bhalla, Anoopindar K., additional, Thomas, Neal J., additional, and Newth, Christopher J. L., additional
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- 2018
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211. Positive End-Expiratory Pressure Lower Than the ARDS Network Protocol Is Associated with Higher Pediatric Acute Respiratory Distress Syndrome Mortality
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Khemani, Robinder G., primary, Parvathaneni, Kaushik, additional, Yehya, Nadir, additional, Bhalla, Anoopindar K., additional, Thomas, Neal J., additional, and Newth, Christopher J. L., additional
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- 2018
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212. Hospital Variation in Intensive Care Resource Utilization and Mortality in Newly Diagnosed Pediatric Leukemia*
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Fitzgerald, Julie C., primary, Li, Yimei, additional, Fisher, Brian T., additional, Huang, Yuan-Shung, additional, Miller, Tamara P., additional, Bagatell, Rochelle, additional, Seif, Alix E., additional, Aplenc, Richard, additional, and Thomas, Neal J., additional
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- 2018
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213. Risk Stratification Using Oxygenation in the First 24 Hours of Pediatric Acute Respiratory Distress Syndrome*
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Yehya, Nadir, primary, Thomas, Neal J., additional, and Khemani, Robinder G., additional
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- 2018
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214. Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis
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Michelson, Kelly N., primary, Reubenson, Gary, additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Ackerman, ; Kate K., additional, Christie, ; LeeAnn, additional, Bush, ; Jenny L., additional, Nadkarni, Vinay M., additional, Thomas, Neal J., additional, and Schreiner, Mark S., additional
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- 2018
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215. Endotype Transitions During the Acute Phase of Pediatric Septic Shock Reflect Changing Risk and Treatment Response
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Wong, Hector R., primary, Cvijanovich, Natalie Z., additional, Anas, Nick, additional, Allen, Geoffrey L., additional, Thomas, Neal J., additional, Bigham, Michael T., additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Checchia, Paul A., additional, Meyer, Keith, additional, Quasney, Michael, additional, Hall, Mark, additional, Gedeit, Rainer, additional, Freishtat, Robert J., additional, Nowak, Jeffrey, additional, Lutfi, Riad, additional, Gertz, Shira, additional, Grunwell, Jocelyn R., additional, and Lindsell, Christopher J., additional
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- 2018
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216. Hyperchloremia Is Associated With Complicated Course and Mortality in Pediatric Patients With Septic Shock*
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Stenson, Erin K., primary, Cvijanovich, Natalie Z., additional, Anas, Nick, additional, Allen, Geoffrey L., additional, Thomas, Neal J., additional, Bigham, Michael T., additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Checchia, Paul A., additional, Meyer, Keith, additional, Quasney, Michael, additional, Hall, Mark, additional, Gedeit, Rainer, additional, Freishtat, Robert J., additional, Nowak, Jeffrey, additional, Raj, Shekhar S., additional, Gertz, Shira, additional, Grunwell, Jocelyn R., additional, and Wong, Hector R., additional
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- 2018
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217. RBC Transfusions Are Associated With Prolonged Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome*
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Zubrow, Michael E., primary, Thomas, Neal J., additional, Friedman, David F., additional, and Yehya, Nadir, additional
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- 2018
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218. Multicohort Analysis of Whole-Blood Gene Expression Data Does Not Form a Robust Diagnostic for Acute Respiratory Distress Syndrome
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Sweeney, Timothy E., primary, Thomas, Neal J., additional, Howrylak, Judie A., additional, Wong, Hector R., additional, Rogers, Angela J., additional, and Khatri, Purvesh, additional
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- 2018
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219. Overlapping MicroRNA Expression in Saliva and Cerebrospinal Fluid Accurately Identifies Pediatric Traumatic Brain Injury
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Hicks, Steven D., primary, Johnson, Jeremiah, additional, Carney, Molly C., additional, Bramley, Harry, additional, Olympia, Robert P., additional, Loeffert, Andrea C., additional, and Thomas, Neal J., additional
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- 2018
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220. A Multi-Center Retrospective Database Evaluation of Pediatric Subjects Diagnosed With Methemoglobinemia.
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Sinha, Neha, Lichak, Brooke, Thomas, Neal J, and Krawiec, Conrad
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METHEMOGLOBINEMIA , *METHYLENE blue , *RESEARCH funding , *HEMOGLOBINS , *SCIENTIFIC observation , *INBORN errors of metabolism , *RETROSPECTIVE studies , *SYMPTOMS , *LONGITUDINAL method , *CLINICAL pathology , *RESEARCH , *ELECTRONIC health records , *CHILDREN - Abstract
Background: Methemoglobinemia requires early identification and treatment, but limited knowledge exists regarding the current therapeutic approach taken by clinicians as well as the outcomes that occur in children. Objectives: To determine the current prevalence of this rare disease in the pediatric population, evaluate the impact of methemoglobin and functional hemoglobin levels, and assess how this disease is approached by clinicians. We hypothesize that methemoglobinemia prevalence is low and more methylene blue use would be observed in subjects with functional hemoglobin levels less than 7 g/dL. Design: This was a retrospective observational cohort study utilizing deidentified TriNetX® electronic health record (EHR) data. Methods: Using a multicenter EHR database, we evaluated subjective characteristics, diagnostic, laboratory results, medication, and procedural codes. Results: Ninety-eight children (mean age 5.3 ± 5.3 years) from 53 healthcare organizations were included. Methemoglobinemia prevalence was 0.0015% with an overall 30-day mortality of 6.1%. Subjects with methemoglobin percentages greater than 20% had a higher frequency of methylene blue administration (70.6% versus 24.7%, P =.0005). Critical care service requirements and methylene blue administration were similar in the subjects with functional hemoglobin less than 7 g/dL and more than 7 g/dL groups. Overall, 13 (13.2%) subjects underwent glucose-6-phosphate dehydrogenase deficiency (G6PD) testing. Conclusion: In our study, we found methemoglobinemia prevalence in children is low, there is a low frequency of G6PD testing despite methylene blue hemolysis risk, and subjects appeared to be treated similarly despite a low functional hemoglobin. These findings highlight the continued critical nature of this disease and may highlight opportunities for education aimed at improving care in children diagnosed with methemoglobinemia, particularly related to G6PD testing. [ABSTRACT FROM AUTHOR]
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- 2024
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221. Neurologic Involvement in Children and Adolescents Hospitalized in the United States for COVID-19 or Multisystem Inflammatory Syndrome
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LaRovere, Kerri L., Riggs, Becky J., Poussaint, Tina Y., Young, Cameron C., Newhams, Margaret M., Maamari, Mia, Walker, Tracie C., Singh, Aalok R., Dapul, Heda, Hobbs, Charlotte V., McLaughlin, Gwenn E., Son, Mary Beth F., Maddux, Aline B., Clouser, Katharine N., Rowan, Courtney M., McGuire, John K., Fitzgerald, Julie C., Gertz, Shira J., Shein, Steven L., Munoz, Alvaro Coronado, Thomas, Neal J., Irby, Katherine, Levy, Emily R., Staat, Mary A., Tenforde, Mark W., Feldstein, Leora R., Halasa, Natasha B., Giuliano, John S., Hall, Mark W., Kong, Michele, Carroll, Christopher L., Schuster, Jennifer E., Doymaz, Sule, Loftis, Laura L., Tarquinio, Keiko M., Babbitt, Christopher J., Nofziger, Ryan A., Kleinman, Lawrence C., Keenaghan, Michael A., Cvijanovich, Natalie Z., Spinella, Philip C., Hume, Janet R., Wellnitz, Kari, Mack, Elizabeth H., Michelson, Kelly N., Flori, Heidi R., Patel, Manish M., and Randolph, Adrienne G.
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IMPORTANCE: Coronavirus disease 2019 (COVID-19) affects the nervous system in adult patients. The spectrum of neurologic involvement in children and adolescents is unclear. OBJECTIVE: To understand the range and severity of neurologic involvement among children and adolescents associated with COVID-19. SETTING, DESIGN, AND PARTICIPANTS: Case series of patients (age <21 years) hospitalized between March 15, 2020, and December 15, 2020, with positive severe acute respiratory syndrome coronavirus 2 test result (reverse transcriptase-polymerase chain reaction and/or antibody) at 61 US hospitals in the Overcoming COVID-19 public health registry, including 616 (36%) meeting criteria for multisystem inflammatory syndrome in children. Patients with neurologic involvement had acute neurologic signs, symptoms, or diseases on presentation or during hospitalization. Life-threatening involvement was adjudicated by experts based on clinical and/or neuroradiologic features. EXPOSURES: Severe acute respiratory syndrome coronavirus 2. MAIN OUTCOMES AND MEASURES: Type and severity of neurologic involvement, laboratory and imaging data, and outcomes (death or survival with new neurologic deficits) at hospital discharge. RESULTS: Of 1695 patients (909 [54%] male; median [interquartile range] age, 9.1 [2.4-15.3] years), 365 (22%) from 52 sites had documented neurologic involvement. Patients with neurologic involvement were more likely to have underlying neurologic disorders (81 of 365 [22%]) compared with those without (113 of 1330 [8%]), but a similar number were previously healthy (195 [53%] vs 723 [54%]) and met criteria for multisystem inflammatory syndrome in children (126 [35%] vs 490 [37%]). Among those with neurologic involvement, 322 (88%) had transient symptoms and survived, and 43 (12%) developed life-threatening conditions clinically adjudicated to be associated with COVID-19, including severe encephalopathy (n = 15; 5 with splenial lesions), stroke (n = 12), central nervous system infection/demyelination (n = 8), Guillain-Barré syndrome/variants (n = 4), and acute fulminant cerebral edema (n = 4). Compared with those without life-threatening conditions (n = 322), those with life-threatening neurologic conditions had higher neutrophil-to-lymphocyte ratios (median, 12.2 vs 4.4) and higher reported frequency of D-dimer greater than 3 μg/mL fibrinogen equivalent units (21 [49%] vs 72 [22%]). Of 43 patients who developed COVID-19–related life-threatening neurologic involvement, 17 survivors (40%) had new neurologic deficits at hospital discharge, and 11 patients (26%) died. CONCLUSIONS AND RELEVANCE: In this study, many children and adolescents hospitalized for COVID-19 or multisystem inflammatory syndrome in children had neurologic involvement, mostly transient symptoms. A range of life-threatening and fatal neurologic conditions associated with COVID-19 infrequently occurred. Effects on long-term neurodevelopmental outcomes are unknown.
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- 2021
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222. New or Progressive Multiple Organ Dysfunction Syndrome in Pediatric Severe Sepsis: A Sepsis Phenotype With Higher Morbidity and Mortality.
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UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Lin, John C, Spinella, Philip C, Fitzgerald, Julie C, Tucci, Marisa, Bush, Jenny L, Nadkarni, Vinay M, Thomas, Neal J, Weiss, Scott L, Sepsis Prevalence, Outcomes, and Therapy Study Investigators, Clément de Cléty, Stéphan, Dujardin, Marie-France, Berghe, Caroline, Renard, Suzanne, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de soins intensifs, Lin, John C, Spinella, Philip C, Fitzgerald, Julie C, Tucci, Marisa, Bush, Jenny L, Nadkarni, Vinay M, Thomas, Neal J, Weiss, Scott L, Sepsis Prevalence, Outcomes, and Therapy Study Investigators, Clément de Cléty, Stéphan, Dujardin, Marie-France, Berghe, Caroline, and Renard, Suzanne
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OBJECTIVES: To describe the epidemiology, morbidity, and mortality of new or progressive multiple organ dysfunction syndrome in children with severe sepsis. DESIGN: Secondary analysis of a prospective, cross-sectional, point prevalence study. SETTING: International, multicenter PICUs. PATIENTS: Pediatric patients with severe sepsis identified on five separate days over a 1-year period. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 567 patients from 128 PICUs in 26 countries enrolled, 384 (68%) developed multiple organ dysfunction syndrome within 7 days of severe sepsis recognition. Three hundred twenty-seven had multiple organ dysfunction syndrome on the day of sepsis recognition. Ninety-one of these patients developed progressive multiple organ dysfunction syndrome, whereas an additional 57 patients subsequently developed new multiple organ dysfunction syndrome, yielding a total proportion with severe sepsis-associated new or progressive multiple organ dysfunction syndrome of 26%. Hospital mortality in patients with progressive multiple organ dysfunction syndrome was 51% compared with patients with new multiple organ dysfunction syndrome (28%) and those with single-organ dysfunction without multiple organ dysfunction syndrome (10%) (p < 0.001). Survivors of new or progressive multiple organ dysfunction syndrome also had a higher frequency of moderate to severe disability defined as a Pediatric Overall Performance Category score of greater than or equal to 3 and an increase of greater than or equal to 1 from baseline: 22% versus 29% versus 11% for progressive, new, and no multiple organ dysfunction syndrome, respectively (p < 0.001). CONCLUSIONS: Development of new or progressive multiple organ dysfunction syndrome is common (26%) in severe sepsis and is associated with a higher risk of morbidity and mortality than severe sepsis without new or progressive multiple organ dysfunction syndrome. Our data support the use of new or progressive multiple organ dysf
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- 2017
223. Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children.
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Moler, Frank W, Moler, Frank W, Silverstein, Faye S, Holubkov, Richard, Slomine, Beth S, Christensen, James R, Nadkarni, Vinay M, Meert, Kathleen L, Browning, Brittan, Pemberton, Victoria L, Page, Kent, Gildea, Marianne R, Scholefield, Barnaby R, Shankaran, Seetha, Hutchison, Jamie S, Berger, John T, Ofori-Amanfo, George, Newth, Christopher JL, Topjian, Alexis, Bennett, Kimberly S, Koch, Joshua D, Pham, Nga, Chanani, Nikhil K, Pineda, Jose A, Harrison, Rick, Dalton, Heidi J, Alten, Jeffrey, Schleien, Charles L, Goodman, Denise M, Zimmerman, Jerry J, Bhalala, Utpal S, Schwarz, Adam J, Porter, Melissa B, Shah, Samir, Fink, Ericka L, McQuillen, Patrick, Wu, Theodore, Skellett, Sophie, Thomas, Neal J, Nowak, Jeffrey E, Baines, Paul B, Pappachan, John, Mathur, Mudit, Lloyd, Eric, van der Jagt, Elise W, Dobyns, Emily L, Meyer, Michael T, Sanders, Ronald C, Clark, Amy E, Dean, J Michael, THAPCA Trial Investigators, Moler, Frank W, Moler, Frank W, Silverstein, Faye S, Holubkov, Richard, Slomine, Beth S, Christensen, James R, Nadkarni, Vinay M, Meert, Kathleen L, Browning, Brittan, Pemberton, Victoria L, Page, Kent, Gildea, Marianne R, Scholefield, Barnaby R, Shankaran, Seetha, Hutchison, Jamie S, Berger, John T, Ofori-Amanfo, George, Newth, Christopher JL, Topjian, Alexis, Bennett, Kimberly S, Koch, Joshua D, Pham, Nga, Chanani, Nikhil K, Pineda, Jose A, Harrison, Rick, Dalton, Heidi J, Alten, Jeffrey, Schleien, Charles L, Goodman, Denise M, Zimmerman, Jerry J, Bhalala, Utpal S, Schwarz, Adam J, Porter, Melissa B, Shah, Samir, Fink, Ericka L, McQuillen, Patrick, Wu, Theodore, Skellett, Sophie, Thomas, Neal J, Nowak, Jeffrey E, Baines, Paul B, Pappachan, John, Mathur, Mudit, Lloyd, Eric, van der Jagt, Elise W, Dobyns, Emily L, Meyer, Michael T, Sanders, Ronald C, Clark, Amy E, Dean, J Michael, and THAPCA Trial Investigators
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BackgroundTargeted temperature management is recommended for comatose adults and children after out-of-hospital cardiac arrest; however, data on temperature management after in-hospital cardiac arrest are limited.MethodsIn a trial conducted at 37 children's hospitals, we compared two temperature interventions in children who had had in-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose children older than 48 hours and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function), was evaluated among patients who had had a VABS-II score of at least 70 before the cardiac arrest.ResultsThe trial was terminated because of futility after 329 patients had undergone randomization. Among the 257 patients who had a VABS-II score of at least 70 before cardiac arrest and who could be evaluated, the rate of the primary efficacy outcome did not differ significantly between the hypothermia group and the normothermia group (36% [48 of 133 patients] and 39% [48 of 124 patients], respectively; relative risk, 0.92; 95% confidence interval [CI], 0.67 to 1.27; P=0.63). Among 317 patients who could be evaluated for change in neurobehavioral function, the change in VABS-II score from baseline to 12 months did not differ significantly between the groups (P=0.70). Among 327 patients who could be evaluated for 1-year survival, the rate of 1-year survival did not differ significantly between the hypothermia group and the normothermia group (49% [81 of 166 patients] and 46% [74 of 161 patients], respectively; relative risk, 1.07; 95% CI, 0.85 to 1.34; P=0.56). The incidences of blood-product use, infection, and
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- 2017
224. Association of Delayed Antimicrobial Therapy with One-Year Mortality in Pediatric Sepsis.
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Han, Moonjoo, Han, Moonjoo, Fitzgerald, Julie C, Balamuth, Fran, Keele, Luke, Alpern, Elizabeth R, Lavelle, Jane, Chilutti, Marianne, Grundmeier, Robert W, Nadkarni, Vinay M, Thomas, Neal J, Weiss, Scott L, Han, Moonjoo, Han, Moonjoo, Fitzgerald, Julie C, Balamuth, Fran, Keele, Luke, Alpern, Elizabeth R, Lavelle, Jane, Chilutti, Marianne, Grundmeier, Robert W, Nadkarni, Vinay M, Thomas, Neal J, and Weiss, Scott L
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ObjectiveDelayed antimicrobial therapy in sepsis is associated with increased hospital mortality, but the impact of antimicrobial timing on long-term outcomes is unknown. We tested the hypothesis that hourly delays to antimicrobial therapy are associated with 1-year mortality in pediatric severe sepsis.DesignRetrospective observational study.SettingQuaternary academic pediatric intensive care unit (PICU) from February 1, 2012 to June 30, 2013.PatientsOne hundred sixty patients aged ≤21 years treated for severe sepsis.InterventionsNone.Measurements and main resultsWe tested the association of hourly delays from sepsis recognition to antimicrobial administration with 1-year mortality using multivariable Cox and logistic regression. Overall 1-year mortality was 24% (39 patients), of whom 46% died after index PICU discharge. Median time from sepsis recognition to antimicrobial therapy was 137 min (IQR 65-287). After adjusting for severity of illness and comorbid conditions, hourly delays up to 3 h were not associated with 1-year mortality. However, increased 1-year mortality was evident in patients who received antimicrobials ≤1 h (aOR 3.8, 95% CI 1.2, 11.7) or >3 h (aOR 3.5, 95% CI 1.3, 9.8) compared with patients who received antimicrobials within 1 to 3 h from sepsis recognition. For the subset of patients who survived index PICU admission, antimicrobial therapy ≤1 h was also associated with increased 1-year mortality (aOR 5.5, 95% CI 1.1, 27.4), while antimicrobial therapy >3 h was not associated with 1-year mortality (aOR 2.2, 95% CI 0.5, 11.0).ConclusionsHourly delays to antimicrobial therapy, up to 3 h, were not associated with 1-year mortality in pediatric severe sepsis in this study. The finding that antimicrobial therapy ≤1 h from sepsis recognition was associated with increased 1-year mortality should be regarded as hypothesis-generating for future studies.
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- 2017
225. Comparison of Pediatric Severe Sepsis Managed in U.S. and European ICUs
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Giuliano, John S, Markovitz, Barry P., Brierley, Joe, Levin, Richard, Williams, Gary, Lum, Lucy Chai See, Dorofaeff, Tavey, Cruces, Pablo, Bush, Jenny L., Keele, Luke, Nadkarni, Vinay M., Thomas, Neal J., Fitzgerald, Julie C., Weiss, Scott L., Fontela, P., Tucci, M., Dumistrascu, M., Skippen, P., Krahn, G., Bezares, E., Puig, G., Puig Ramos, A., Garcia, R., Villar, M., Bigham, M., Polanski, T., Latifi, S., Giebner, D., Anthony, H., Hume, J., Galster, A., Linnerud, L., Sanders, R., Hefley, G., Madden, K., Thompson, A., Shein, S., Gertz, S., Han, Y., Williams, T., Hughes Schalk, A., Chandler, H., Orioles, A., Zielinski, E., Doucette, A., Zebuhr, C., Wilson, T., Dimitriades, C., Ascani, J., Layburn, S., Valley, S., Markowitz, B., Terry, J., Morzov, R., Mcinnes, A., Mcarthur, J., Woods, K., Murkowski, K., Spaeder, M., Sharron, M., Wheeler, D., Beckman, E., Frank, E., Howard, K., Carroll, C., Nett, S., Jarvis, D., Patel, V., Higgerson, R., Christie, L., Typpo, K., Deschenes, J., Kirby, A., Uhl, T., Rehder, K., Cheifetz, I., Wrenn, S., Kypuros, K., Ackerman, K., Maffei, F., Bloomquist, G., Rizkalla, N., Kimura, D., Shah, S., Tigges, C., Su, F., Barlow, C., Michelson, K., Wolfe, K., Goodman, D., Campbell, L., Sorce, L., Bysani, K., Monjure, T., Evans, M., Totapally, B., Chegondi, M., Rodriguez, C., Frazier, J., Steele, L., Viteri, S., Costarino, A., Thomas, N., Spear, D., Hirshberg, E., Lilley, J., Rowan, C., Rider, C., Kane, J., Zimmerman, J., Greeley, C., Lin, J., Jacobs, R., Parker, M., Culver, K., Loftis, L., Jaimon, N., Goldsworthy, M., Fitzgerald, J., Weiss, S., Nadkarni, V., Bush, J., Diliberto, M., Alen, C., Gessouroun, M., Sapru, A., Lang, T., Alkhouli, M., Kamath, S., Friel, D., Daufeldt, J., Hsing, D., Carlo, C., Pon, S., Scimeme, J., Shaheen, A., Hassinger, A., Qiao, H., Giuliano, J., Tala, J., Vinciguerra, D., Fernandez, A., Carrero, R., Hoyos, P., Jaramillo, J., Posada, A., Izquiierdo, L., Piñeres Olave, B. E., Donado, J., Dalmazzo, R., Rendich, S., Palma, L., Lapadula, M., Acuna, C., Cruces, P., Clement De Clety, S., Dujardin, M., Berghe, C., Renard, S., Zurek, J., Steinherr, H., Mougkou, K., Critselis, E., Di Nardo, M., Picardo, S., Tortora, F., Rossetti, E., Fragasso, T., Cogo, Paola, Netto, R., Dagys, A., Gurskis, V., Kevalas, R., Neeleman, C., Lemson, J., Luijten, C., Wojciech, K., Pagowska Klimek, I., Szczepanska, M., Karpe, J., Nunes, P., Almeida, H., Rios, J., Vieira, M., Revilla, P., Urbano, J., Lopez Herce, J., Bustinza, A., Cuesta, A., Hofheinz, S., Rodriguez Nunez, A., Sanagustin, S., Gonzalez, E., Riaza, M., Piaya, R., Soler, P., Esteban, E., Laraudogoitia, J., Monge, C., Herrera, V., Granados, J., Gonzalez, C., Koroglu, T., Ozcelik, E., Baines, P., Plunkett, A., Davis, P., George, S., Tibby, S., Harris, J., Agbeko, R., Lampitt, R., Brierley, J., Peters, M., Jones, A., Dominguez, T., Thiruchelvam, T., Deep, A., Ridley, L., Bowen, W., Levin, R., Macleod, I., Gray, M., Hemat, N., Alexander, J., Ali, S., Pappachan, J., Mccorkell, J., Fortune, P., Macdonald, M., Hudnott, P., Suyun, Q., Singhi, S., Nallasamy, K., Lodha, R., Shime, N., Tabata, Y., Saito, O., Ikeyama, T., Kawasaki, T., Lum, L., Abidin, A., Kee, S., Tang, S., Jalil, R., Guan, Y., Yao, L., Lin, K., Ong, J., Salloo, A., Doedens, L., Mathivha, L., Reubenson, G., Moaisi, S., Pentz, A., Green, R., Schibler, A., Erickson, S., Mceneiry, J., Long, D., Dorofaeff, T., Coulthard, M., Millar, J., Delzoppo, C., Williams, G., Morritt, M., Watts, N., Beca, J., Sherring, C., and Bushell, T.
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Male ,Pediatrics ,Cross-sectional study ,shock ,Critical Care and Intensive Care Medicine ,Severity of Illness Index ,0302 clinical medicine ,Prevalence ,Hospital Mortality ,Prospective Studies ,030212 general & internal medicine ,Practice Patterns, Physicians' ,Child ,Prospective cohort study ,Pediatric intensive care unit ,Perinatology and Child Health ,Europe ,Treatment Outcome ,Child, Preschool ,outcome ,children ,management ,pediatric intensive care unit ,Pediatrics, Perinatology and Child Health ,Female ,medicine.symptom ,medicine.medical_specialty ,Adolescent ,Critical Care ,Intensive Care Units, Pediatric ,Sepsis ,03 medical and health sciences ,Intensive care ,Severity of illness ,medicine ,Humans ,Healthcare Disparities ,business.industry ,Organ dysfunction ,Infant, Newborn ,Infant ,030208 emergency & critical care medicine ,Health Status Disparities ,medicine.disease ,United States ,Clinical trial ,Cross-Sectional Studies ,Multivariate Analysis ,Emergency medicine ,business - Abstract
Copyright © 2016 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.Objectives: Pediatric severe sepsis remains a significant global health problem without new therapies despite many multicenter clinical trials. We compared children managed with severe sepsis in European and U.S. PICUs to identify geographic variation, which may improve the design of future international studies. Design: We conducted a secondary analysis of the Sepsis PRevalence, OUtcomes, and Therapies study. Data about PICU characteristics, patient demographics, therapies, and outcomes were compared. Multivariable regression models were used to determine adjusted differences in morbidity and mortality. Setting: European and U.S. PICUs. Patients: Children with severe sepsis managed in European and U.S. PICUs enrolled in the Sepsis PRevalence, OUtcomes, and Therapies study. Interventions: None. Measurements and Main Results: European PICUs had fewer beds (median, 11 vs 24; p < 0.001). European patients were younger (median, 1 vs 6 yr; p < 0.001), had higher severity of illness (median Pediatric Index of Mortality-3, 5.0 vs 3.8; p = 0.02), and were more often admitted from the ward (37% vs 24%). Invasive mechanical ventilation, central venous access, and vasoactive infusions were used more frequently in European patients (85% vs 68%, p = 0.002; 91% vs 82%, p = 0.05; and 71% vs 50%; p < 0.001, respectively). Raw morbidity and mortality outcomes were worse for European compared with U.S. patients, but after adjusting for patient characteristics, there were no significant differences in mortality, multiple organ dysfunction, disability at discharge, length of stay, or ventilator/vasoactive-free days. Conclusions: Children with severe sepsis admitted to European PICUs have higher severity of illness, are more likely to be admitted from hospital wards, and receive more intensive care therapies than in the United States. The lack of significant differences in morbidity and mortality after adjusting for patient characteristics suggests that the approach to care between regions, perhaps related to PICU bed availability, needs to be considered in the design of future international clinical trials in pediatric severe sepsis.
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- 2016
226. Tracheal aspirate transcriptomic and miRNA signatures of extreme premature birth with bronchopulmonary dysplasia
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Oji-Mmuo, Christiana N., Siddaiah, Roopa, Montes, Deborah T., Pham, Melody A., Spear, Debra, Donnelly, Ann, Fuentes, Nathalie, Imamura-Kawasawa, Yuka, Howrylak, Judie A., Thomas, Neal J., and Silveyra, Patricia
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Objective: Extreme preterm infants are a growing population in neonatal intensive care units who carry a high mortality and morbidity. Multiple factors play a role in preterm birth, resulting in major impact on organogenesis leading to complications including bronchopulmonary dysplasia (BPD). The goal of this study was to identify biomarker signatures associated with prematurity and BPD. Study design: We analyzed miRNA and mRNA profiles in tracheal aspirates (TAs) from 55 infants receiving invasive mechanical ventilation. Twenty-eight infants were extremely preterm and diagnosed with BPD, and 27 were term babies receiving invasive mechanical ventilation for elective procedures. Result: We found 22 miRNAs and 33 genes differentially expressed (FDR < 0.05) in TAs of extreme preterm infants with BPD vs. term babies without BPD. Pathway analysis showed associations with inflammatory response, cellular growth/proliferation, and tissue development. Conclusions: Specific mRNA-miRNA signatures in TAs may serve as biomarkers for BPD pathogenesis, a consequence of extreme prematurity.
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- 2021
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227. Improved Risk Stratification in Pediatric Septic Shock Using Both Protein and mRNA Biomarkers. PERSEVERE-XP
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Wong, Hector R., primary, Cvijanovich, Natalie Z., additional, Anas, Nick, additional, Allen, Geoffrey L., additional, Thomas, Neal J., additional, Bigham, Michael T., additional, Weiss, Scott L., additional, Fitzgerald, Julie C., additional, Checchia, Paul A., additional, Meyer, Keith, additional, Quasney, Michael, additional, Hall, Mark, additional, Gedeit, Rainer, additional, Freishtat, Robert J., additional, Nowak, Jeffrey, additional, Raj, Shekhar S., additional, Gertz, Shira, additional, Grunwell, Jocelyn R., additional, and Lindsell, Christopher J., additional
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- 2017
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228. A Multiplex Electrochemical Biosensor for Bloodstream Infection Diagnosis
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Gao, Jian, primary, Jeffries, Lindsie, additional, Mach, Kathleen E., additional, Craft, David W., additional, Thomas, Neal J., additional, Gau, Vincent, additional, Liao, Joseph C., additional, and Wong, Pak Kin, additional
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- 2017
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229. Challenges With Implementation of a Respiratory Therapist–Driven Protocol of Spontaneous Breathing Trials in the Pediatric ICU
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Krawiec, Conrad, primary, Carl, Dale, additional, Stetter, Christy, additional, Kong, Lan, additional, Ceneviva, Gary D, additional, and Thomas, Neal J, additional
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- 2017
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230. Association of Delayed Antimicrobial Therapy with One-Year Mortality in Pediatric Sepsis
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Han, Moonjoo, primary, Fitzgerald, Julie C., additional, Balamuth, Fran, additional, Keele, Luke, additional, Alpern, Elizabeth R., additional, Lavelle, Jane, additional, Chilutti, Marianne, additional, Grundmeier, Robert W., additional, Nadkarni, Vinay M., additional, Thomas, Neal J., additional, and Weiss, Scott L., additional
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- 2017
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231. Disassociating Lung Mechanics and Oxygenation in Pediatric Acute Respiratory Distress Syndrome*
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Yehya, Nadir, primary and Thomas, Neal J., additional
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- 2017
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232. The authors reply
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Lin, John C., primary, Spinella, Philip C., additional, Fitzgerald, Julie C., additional, Tucci, Marisa, additional, Bush, Jenny L., additional, Nadkarni, Vinay M., additional, Thomas, Neal J., additional, and Weiss, Scott L., additional
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- 2017
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233. Glucocorticoid Receptor Polymorphisms and Outcomes in Pediatric Septic Shock*
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Cvijanovich, Natalie Z., primary, Anas, Nick, additional, Allen, Geoffrey L., additional, Thomas, Neal J., additional, Bigham, Michael T., additional, Weiss, Scott L., additional, Fitzgerald, Julie, additional, Checchia, Paul A., additional, Meyer, Keith, additional, Quasney, Michael, additional, Gedeit, Rainer, additional, Freishtat, Robert J., additional, Nowak, Jeffrey, additional, Raj, Shekhar S., additional, Gertz, Shira, additional, Grunwell, Jocelyn R., additional, Opoka, Amy, additional, and Wong, Hector R., additional
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- 2017
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234. Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children
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Moler, Frank W., primary, Silverstein, Faye S., additional, Holubkov, Richard, additional, Slomine, Beth S., additional, Christensen, James R., additional, Nadkarni, Vinay M., additional, Meert, Kathleen L., additional, Browning, Brittan, additional, Pemberton, Victoria L., additional, Page, Kent, additional, Gildea, Marianne R., additional, Scholefield, Barnaby R., additional, Shankaran, Seetha, additional, Hutchison, Jamie S., additional, Berger, John T., additional, Ofori-Amanfo, George, additional, Newth, Christopher J.L., additional, Topjian, Alexis, additional, Bennett, Kimberly S., additional, Koch, Joshua D., additional, Pham, Nga, additional, Chanani, Nikhil K., additional, Pineda, Jose A., additional, Harrison, Rick, additional, Dalton, Heidi J., additional, Alten, Jeffrey, additional, Schleien, Charles L., additional, Goodman, Denise M., additional, Zimmerman, Jerry J., additional, Bhalala, Utpal S., additional, Schwarz, Adam J., additional, Porter, Melissa B., additional, Shah, Samir, additional, Fink, Ericka L., additional, McQuillen, Patrick, additional, Wu, Theodore, additional, Skellett, Sophie, additional, Thomas, Neal J., additional, Nowak, Jeffrey E., additional, Baines, Paul B., additional, Pappachan, John, additional, Mathur, Mudit, additional, Lloyd, Eric, additional, van der Jagt, Elise W., additional, Dobyns, Emily L., additional, Meyer, Michael T., additional, Sanders, Ronald C., additional, Clark, Amy E., additional, and Dean, J. Michael, additional
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- 2017
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235. Genetic association and epistatic interaction of the interleukin-10 signaling pathway in pediatric inflammatory bowel disease
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Lin, Zhenwu, primary, Wang, Zhong, additional, Hegarty, John P, additional, Lin, Tony R, additional, Wang, Yunhua, additional, Deiling, Sue, additional, Wu, Rongling, additional, Thomas, Neal J, additional, and Floros, Joanna, additional
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- 2017
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236. Cytokine Panels and Pediatric Acute Respiratory Distress Syndrome: A Translational Investigation*
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McKeone, Daniel J., Mathewson, Margaret, Dalal, Priti G., Spear, Debbie, Umstead, Todd M., Hicks, Steven D., Chroneos, Zissis C., Wang, Ming, Thomas, Neal J., and Halstead, E. Scott
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Supplemental Digital Content is available in the text.
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- 2020
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237. Design and Rationale for Common Data Elements for Clinical Research in Pediatric Critical Care Medicine
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Ward, Shan L., Flori, Heidi R., Bennett, Tellen D., Sapru, Anil, Mourani, Peter M., Thomas, Neal J., and Khemani, Robinder G.
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- 2020
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238. Variation in Practice Related to the Use of High Flow Nasal Cannula in Critically Ill Children
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Kawaguchi, Atsushi, Garros, Daniel, Joffe, Ari, DeCaen, Allan, Thomas, Neal J., Schibler, Andreas, Pons-Odena, Marti, Udani, Soonu, Takeuchi, Muneyuki, Junior, José Colleti, and Ramnarayan, Padmanabhan
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Supplemental Digital Content is available in the text.
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- 2020
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239. Specific Viral Etiologies Are Associated With Outcomes in Pediatric Acute Respiratory Distress Syndrome.
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Roberts, Anna L., Sammons, Julia S., Mourani, Peter M., Thomas, Neal J., and Yehya, Nadir
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- 2019
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240. Adaptable microfluidic system for single-cell pathogen classification and antimicrobial susceptibility testing.
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Hui Li, Torab, Peter, Mach, Kathleen E., Surrette, Christine, England, Matthew R., Craft, David W., Thomas, Neal J., Liao, Joseph C., Puleo, Chris, and Pak Kin Wong
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BACTERIAL diseases ,ANTIBIOTICS ,MICROBIAL sensitivity tests ,URINALYSIS ,BACTERIAL growth - Abstract
Infectious diseases caused by bacterial pathogens remain one of the most common causes of morbidity and mortality worldwide. Rapid microbiological analysis is required for prompt treatment of bacterial infections and to facilitate antibiotic stewardship. This study reports an adaptable microfluidic system for rapid pathogen classification and antimicrobial susceptibility testing (AST) at the single-cell level. By incorporating tunable microfluidic valves along with real-time optical detection, bacteria can be trapped and classified according to their physical shape and size for pathogen classification. By monitoring their growth in the presence of antibiotics at the single-cell level, antimicrobial susceptibility of the bacteria can be determined in as little as 30 minutes compared with days required for standard procedures. The microfluidic system is able to detect bacterial pathogens in urine, blood cultures, and whole blood and can analyze polymicrobial samples. We pilot a study of 25 clinical urine samples to demonstrate the clinical applicability of the microfluidic system. The platform demonstrated a sensitivity of 100% and specificity of 83.33% for pathogen classification and achieved 100% concordance for AST. [ABSTRACT FROM AUTHOR]
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- 2019
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241. Short-Term Adverse Outcomes Associated With Hypoglycemia in Critically Ill Children.
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Faustino, Edward Vincent S., Hirshberg, Eliotte L., Asaro, Lisa A., Biagas, Katherine V., Pinto, Neethi, Srinivasan, Vijay, Bagdure, Dayanand N., Steil, Garry M., Coughlin-Wells, Kerry, Wypij, David, Nadkarni, Vinay M., Agus, Michael S. D., Heart And Lung Failure-Pediatric INsulin Titration (HALF-PINT) Study Investigators, Mourani, Peter M, Chima, Ranjit, Thomas, Neal J, Li, Simon, Pinto, Alan, Newth, Christopher, and Hassinger, Amanda
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- 2019
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242. Nanotube assisted microwave electroporation for single cell pathogen identification and antimicrobial susceptibility testing.
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Gao, Jian, Li, Hui, Torab, Peter, Mach, Kathleen E., Craft, David W., Thomas, Neal J., Puleo, Chris M., Liao, Joseph C., Wang, Tza-Huei, and Wong, Pak Kin
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MICROBIAL sensitivity tests ,PATHOGENIC bacteria ,MEDICAL microbiology ,ELECTROPORATION ,BACTERIAL cells ,MICROWAVES - Abstract
A nanotube assisted microwave electroporation (NAME) technique is demonstrated for delivering molecular biosensors into viable bacteria for multiplex single cell pathogen identification to advance rapid diagnostics in clinical microbiology. Due to the small volume of a bacterial cell (~femtoliter), the intracellular concentration of the target molecule is high, which results in a strong signal for single cell detection without amplification. The NAME procedure can be completed in as little as 30 minutes and can achieve over 90% transformation efficiency. We demonstrate the feasibility of NAME for identifying clinical isolates of bloodborne and uropathogenic pathogens and detecting bacterial pathogens directly from patient's samples. In conjunction with a microfluidic single cell trapping technique, NAME allows single cell pathogen identification and antimicrobial susceptibility testing concurrently. Using this approach, the time for microbiological analysis reduces from days to hours, which will have a significant impact on the clinical management of bacterial infections. A nanotube assisted microwave electroporation (NAME) technique is demonstrated for rapid microbiological analysis of pathogenic bacteria. NAME delivers molecular biosensors into viable bacteria for multiplex single cell pathogen identification and antimicrobial susceptibility testing. The technique determines the species in as little as 30 minutes and perform antimicrobial susceptibility testing in less than 3 hours. Unlabelled Image [ABSTRACT FROM AUTHOR]
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- 2019
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243. Vancomycin Prescribing and Therapeutic Drug Monitoring in Children With and Without Acute Kidney Injury After Cardiac Arrest.
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Fitzgerald, Julie C., Zane, Nicole R., Himebauch, Adam S., Reedy, Michael D., Downes, Kevin J., Topjian, Alexis A., Furth, Susan L., Thomas, Neal J., Scheetz, Marc H., and Zuppa, Athena F.
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ACUTE kidney failure ,DRUG monitoring ,CARDIAC arrest ,VANCOMYCIN ,GLOMERULAR filtration rate - Abstract
Background: Acute kidney injury (AKI) commonly occurs after cardiac arrest. Those subsequently treated with vancomycin are at additional risk for drug-induced kidney injury. Objective: We aimed to determine whether opportunities exist for improved drug monitoring after cardiac arrest. Methods: This was a retrospective cohort study of children aged 30 days–17 years treated after cardiac arrest in an intensive care unit from January 2010 to September 2014 who received vancomycin within 24 h of arrest. Vancomycin dosing and monitoring were compared between those with and without AKI, with AKI defined as pRIFLE (pediatric risk, injury, failure, loss, end-stage renal disease) stage 2–3 AKI at day 5 using Schwartz formula-calculated estimated glomerular filtration rate (eGFR). Results: Of 43 children, 16 (37%) had AKI at day 5. Age, arrest duration, median time to first vancomycin dose, and the number of doses before and time to first vancomycin concentration measurement were similar between groups. Children with AKI had higher initial vancomycin concentrations than those without AKI (median 16 vs. 7 mg/L; p = 0.003). A concentration was not measured before the second dose in 44% of children with AKI. Initial eGFR predicted day 5 AKI. In children with AKI, the initial eGFR was lower in those with than those without a concentration measurement before the second dose (29 mL/min/1.73 m
2 [interquartile range (IQR) 23–47] vs. 52 [IQR 50–57]; p = 0.03) but well below normal in both. Conclusions: In children with AKI after cardiac arrest, decreased vancomycin clearance was evident early, and early monitoring was not performed universally in those with low initial eGFR. Earlier vancomycin therapeutic drug monitoring is indicated in this high-risk population. [ABSTRACT FROM AUTHOR]- Published
- 2019
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244. Tracking resident pre-rounding electronic health record usage.
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Krawiec, Conrad, Marker, Cristin, Stetter, Christy, Kong, Lan, and Thomas, Neal J.
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Purpose: Residents collect information from the electronic health record (EHR) to present during rounds, but this crucial process is understudied. The purpose of this paper is to examine the feasibility of utilizing an EHR embedded time-tracking software to quantify resident pre-round EHR activity and how patient acuity impacts this activity.Design/methodology/approach: This was a retrospective observational study that quantified resident EHR activities (total time spent, tasks performed and patient encounters accessed) during pre-rounds on their pediatric intensive care unit rotation between May 2016 and December 2016. Patient encounters were reviewed to determine resident ownership and critical care resources provided.Findings: Allo 21 eligible participants were included. In total, 907 patient encounters were included to evaluate patient acuity impact. EHR usage per patient encounter (median in minutes (25th, 75th percentile)) was significantly affected by the critical care resources utilized. Total EHR time: both ventilator and vasoactive support (10.54 (6.68, 17.19)); neither ventilator nor vasoactive support (8.23 (5.07, 12.72)); invasive/noninvasive ventilator support (8.74 (5.69, 13.2)); and vasoactive support (10.37 (7.72, 11.65)), p<0.001. Chart review, order entry and documentation EHR times demonstrated similar trends.Practical Implications: Residents spend more time utilizing the EHR to collect data on patients who require significant critical care resources. This information can be useful to determine optimal resident to patient workload. Future research is required to assess this EHR tool's ability to contribute to physician workflow study.Originality/value: EHR embedded time-tracking software can offer insights into resident workflow. [ABSTRACT FROM AUTHOR]- Published
- 2019
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245. Association Between Tidal Volumes Adjusted for Ideal Body Weight and Outcomes in Pediatric Acute Respiratory Distress Syndrome.
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Imber, David A., Thomas, Neal J., and Yehya, Nadir
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- 2019
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246. Assessing and Improving Documentation of Pediatric Brain Death Determination within an Electronic Health Record.
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Krawiec, Conrad, Ceneviva, Gary D., and Thomas, Neal J.
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BRAIN death ,ELECTRONIC health records - Abstract
Background/Objective Pediatric brain death determination (BDD) can be subject to interprovider variability of documentation, resulting in diagnosis credibility. The aim of this study was to describe our approach to assessing pediatric BDD documentation and documentation variation in the electronic health record (EHR). Methods This was a single institution cross-sectional review of pediatric patients younger than 18 years determined to meet brain death criteria. We assessed electronic documentation and evaluated for the presence of contributing factors that can interfere with the brain death documentation based on our institutional brain death evaluation policy (core body temperature, systolic blood pressure within an acceptable range, sedative/analgesic drug effects, and neuromuscular blockade). Results In total, 33 pediatric brain death patients were identified. This review revealed pediatric BDD documentation consistency (n , %) as follows: performance of the first pediatric brain death clinical examination with temperature above 36°C (27, 81.8%), systolic blood pressure above the defined range (29, 87.9%), more than 24 hours following admission (28, 84.8%); performance of the second pediatric brain death clinical examination with temperature above 36°C (32, 97%), more than 12 hours following the first examination (26, 89.7%); and ensuring sedative infusions were discontinued within the recommended cutoff period prior to pediatric BDD (28, 84.8%). Clinical neurologic examinations were fully documented. Conclusions Pediatric BDD is a rare process subject to documentation omissions and error. Our findings highlight the variability of pediatric BDD electronic documentation among different providers and specialties at our institution. An approach to improving pediatric BDD documentation may start with completing a standardized electronic brain death document. [ABSTRACT FROM AUTHOR]
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- 2019
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247. Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study.
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Khemani, Robinder G, Smith, Lincoln, Lopez-Fernandez, Yolanda M, Kwok, Jeni, Morzov, Rica, Klein, Margaret J, Yehya, Nadir, Willson, Douglas, Kneyber, Martin C J, Lillie, Jon, Fernandez, Analia, Newth, Christopher J L, Jouvet, Philippe, and Thomas, Neal J
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ADULT respiratory distress syndrome ,NONINVASIVE ventilation ,BLOOD gases ,HEART diseases ,MEDICINE - Abstract
Summary Background Paediatric acute respiratory distress syndrome (PARDS) is associated with high mortality in children, but until recently no paediatric-specific diagnostic criteria existed. The Pediatric Acute Lung Injury Consensus Conference (PALICC) definition was developed to overcome limitations of the Berlin definition, which was designed and validated for adults. We aimed to determine the incidence and outcomes of children who meet the PALICC definition of PARDS. Methods In this international, prospective, cross-sectional, observational study, 145 paediatric intensive care units (PICUs) from 27 countries were recruited, and over a continuous 5 day period across 10 weeks all patients were screened for enrolment. Patients were included if they had a new diagnosis of PARDS that met PALICC criteria during the study week. Exclusion criteria included meeting PARDS criteria more than 24 h before screening, cyanotic heart disease, active perinatal lung disease, and preparation or recovery from a cardiac intervention. Data were collected on the PICU characteristics, patient demographics, and elements of PARDS (ie, PARDS risk factors, hypoxaemia severity metrics, type of ventilation), comorbidities, chest imaging, arterial blood gas measurements, and pulse oximetry. The primary outcome was PICU mortality. Secondary outcomes included 90 day mortality, duration of invasive mechanical and non-invasive ventilation, and cause of death. Findings Between May 9, 2016, and June 16, 2017, during the 10 study weeks, 23 280 patients were admitted to participating PICUs, of whom 744 (3·2%) were identified as having PARDS. 95% (708 of 744) of patients had complete data for analysis, with 17% (121 of 708; 95% CI 14–20) mortality, whereas only 32% (230 of 708) of patients met Berlin criteria with 27% (61 of 230) mortality. Based on hypoxaemia severity at PARDS diagnosis, mortality was similar among those who were non-invasively ventilated and with mild or moderate PARDS (10–15%), but higher for those with severe PARDS (33% [54 of 165; 95% CI 26–41]). 50% (80 of 160) of non-invasively ventilated patients with PARDS were subsequently intubated, with 25% (20 of 80; 95% CI 16–36) mortality. By use of PALICC PARDS definition, severity of PARDS at 6 h after initial diagnosis (area under the curve [AUC] 0·69, 95% CI 0·62–0·76) discriminates PICU mortality better than severity at PARDS diagnosis (AUC 0·64, 0·58–0·71), and outperforms Berlin severity groups at 6 h (0·64, 0·58–0·70; p=0·01). Interpretation The PALICC definition identified more children as having PARDS than the Berlin definition, and PALICC PARDS severity groupings improved the stratification of mortality risk, particularly when applied 6 h after PARDS diagnosis. The PALICC PARDS framework should be considered for use in future epidemiological and therapeutic research among children with PARDS. Funding University of Southern California Clinical Translational Science Institute, Sainte Justine Children's Hospital, University of Montreal, Canada, Réseau en Santé Respiratoire du Fonds de Recherche Quebec-Santé, and Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care Medicine. [ABSTRACT FROM AUTHOR]
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- 2019
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248. Vancomycin Monotherapy May Be Insufficient to Treat Methicillin-resistant Staphylococcus aureus Coinfection in Children With Influenza-related Critical Illness.
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Randolph, Adrienne G, Xu, Ruifei, Novak, Tanya, Newhams, Margaret M, Wardenburg, Juliane Bubeck, Weiss, Scott L, Sanders, Ronald C, Thomas, Neal J, Hall, Mark W, Tarquinio, Keiko M, Cvijanovich, Natalie, Gedeit, Rainer G, Truemper, Edward J, Markovitz, Barry, Hartman, Mary E, Ackerman, Kate G, Giuliano, John S, Shein, Steven L, Moffitt, Kristin L, and Network, Pediatric Intensive Care Influenza Investigators from the Pediatric Acute Lung Injury and Sepsis Investigator's
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PNEUMONIA-related mortality ,CONFIDENCE intervals ,DRUG resistance in microorganisms ,INFLUENZA ,INTENSIVE care units ,ORTHOMYXOVIRUSES ,PEDIATRICS ,PNEUMONIA ,RESPIRATORY insufficiency ,VANCOMYCIN ,RELATIVE medical risk ,TREATMENT effectiveness ,METHICILLIN-resistant staphylococcus aureus ,MIXED infections ,PHARMACODYNAMICS ,SYMPTOMS ,PROGNOSIS - Abstract
Background Coinfection with influenza virus and methicillin-resistant Staphylococcus aureus (MRSA) causes life-threatening necrotizing pneumonia in children. Sporadic incidence precludes evaluation of antimicrobial efficacy. We assessed the clinical characteristics and outcomes of critically ill children with influenza–MRSA pneumonia and evaluated antibiotic use. Methods We enrolled children (<18 years) with influenza infection and respiratory failure across 34 pediatric intensive care units 11/2008–5/2016. We compared baseline characteristics, clinical courses, and therapies in children with MRSA coinfection, non-MRSA bacterial coinfection, and no bacterial coinfection. Results We enrolled 170 children (127 influenza A, 43 influenza B). Children with influenza–MRSA pneumonia (N = 30, 87% previously healthy) were older than those with non-MRSA (N = 61) or no (N = 79) bacterial coinfections. Influenza–MRSA was associated with increased leukopenia, acute lung injury, vasopressor use, extracorporeal life support, and mortality than either group (P ≤.0001). Influenza-related mortality was 40% with MRSA compared to 4.3% without (relative risk [RR], 9.3; 95% confidence interval [CI], 3.8–22.9). Of 29/30 children with MRSA who received vancomycin within the first 24 hours of hospitalization, mortality was 12.5% (N = 2/16) if treatment also included a second anti-MRSA antibiotic compared to 69.2% (N = 9/13) with vancomycin monotherapy (RR, 5.5; 95% CI, 1.4, 21.3; P =.003). Vancomycin dosing did not influence initial trough levels; 78% were <10 µg/mL. Conclusions Influenza–MRSA coinfection is associated with high fatality in critically ill children. These data support early addition of a second anti-MRSA antibiotic to vancomycin in suspected severe cases. [ABSTRACT FROM AUTHOR]
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- 2019
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249. A Multicenter Retrospective Evaluation of Social Determinant of Health Z Code Usage among Pediatric Patients with Critical Care Visits during Pediatric Critical Care
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Yoder, Lisa, Williams, Duane, Tian, Zizhong, Shen, Chan, Zhou, Shouhao, Thomas, Neal J., and Krawiec, Conrad
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- 2024
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250. Acute Kidney Injury in Pediatric Severe Sepsis: An Independent Risk Factor for Death and New Disability.
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UCL - (SLuc) Service de soins intensifs, Fitzgerald, Julie C, Basu, Rajit K, Akcan-Arikan, Ayse, Izquierdo, Ledys M, Piñeres Olave, Byron E, Hassinger, Amanda B, Szczepanska, Maria, Deep, Akash, Williams, Duane, Sapru, Anil, Roy, Jason A, Nadkarni, Vinay M, Thomas, Neal J, Weiss, Scott L, Furth, Susan, SPROUT Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, Clément de Cléty, Stéphan, UCL - (SLuc) Service de soins intensifs, Fitzgerald, Julie C, Basu, Rajit K, Akcan-Arikan, Ayse, Izquierdo, Ledys M, Piñeres Olave, Byron E, Hassinger, Amanda B, Szczepanska, Maria, Deep, Akash, Williams, Duane, Sapru, Anil, Roy, Jason A, Nadkarni, Vinay M, Thomas, Neal J, Weiss, Scott L, Furth, Susan, SPROUT Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network, and Clément de Cléty, Stéphan
- Abstract
OBJECTIVES: The prevalence of septic acute kidney injury and impact on functional status of PICU survivors are unknown. We used data from an international prospective severe sepsis study to elucidate functional outcomes of children suffering septic acute kidney injury. DESIGN: Secondary analysis of patients in the Sepsis PRevalence, OUtcomes, and Therapies point prevalence study: acute kidney injury was defined on the study day using Kidney Disease Improving Global Outcomes definitions. Patients with no acute kidney injury or stage 1 acute kidney injury ("no/mild acute kidney injury") were compared with those with stage 2 or 3 acute kidney injury ("severe acute kidney injury"). The primary outcome was a composite of death or new moderate disability at discharge defined as a Pediatric Overall Performance Category score of 3 or higher and increased by 1 from baseline. SETTING: One hundred twenty-eight PICUs in 26 countries. PATIENTS: Children with severe sepsis in the Sepsis PRevalence, OUtcomes, and Therapies study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: One hundred two (21%) of 493 patients had severe acute kidney injury. More than twice as many patients with severe acute kidney injury died or developed new moderate disability compared with those with no/mild acute kidney injury (64% vs 30%; p < 0.001). Severe acute kidney injury was independently associated with death or new moderate disability (adjusted odds ratio, 2.5; 95% CI, 1.5-4.2; p = 0.001) after adjustment for age, region, baseline disability, malignancy, invasive mechanical ventilation, albumin administration, and the pediatric logistic organ dysfunction score. CONCLUSIONS: In a multinational cohort of critically ill children with severe sepsis and high mortality rates, septic acute kidney injury is independently associated with further increased death or new disability.
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- 2016
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