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Browsing by Author "Klein, Margaret J."
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Item Changes in Pediatric ICU Utilization and Clinical Trends During the Coronavirus Pandemic(Elsevier, 2021) Zee-Cheng, Janine; McCluskey, Casey K.; Klein, Margaret J.; Scanlon, Matthew C.; Rotta, Alexandre T.; Shein, Steven L.; Pineda, Jose A.; Remy, Kenneth E.; Carroll, Christopher L.; Pediatrics, School of MedicineBackground Children have been less affected by the COVID-19 pandemic, but its repercussions on pediatric illnesses may have been significant. This study examines the indirect impact of the pandemic on a population of critically ill children in the United States. Research Question Were there significantly fewer critically ill children admitted to PICUs during the second quarter of 2020, and were there significant changes in the types of diseases admitted? Study Design and Methods This retrospective observational cohort study used the Virtual Pediatric Systems database. Participants were 160,295 children admitted to the PICU at 77 sites in the United States during quarters 1 (Q1) and 2 (Q2) of 2017 to 2019 (pre-COVID-19) and 2020 (COVID-19). Results The average number of admissions was similar between pre-COVID-19 Q1 and COVID-19 Q1 but decreased by 32% from pre-COVID-19 Q2 to COVID-19 Q2 (20,157 to 13,627 admissions per quarter). The largest decreases were in respiratory conditions, including asthma (1,327 subjects in pre-COVID-19 Q2 (6.6% of patients) vs 241 subjects in COVID-19 Q2 (1.8%; P < .001) and bronchiolitis (1,299 [6.5%] vs 121 [0.9%]; P < .001). The percentage of trauma admissions increased, although the raw number of trauma admissions decreased. Admissions for diabetes mellitus and poisoning/ingestion also increased. In the multivariable model, illness severity-adjusted odds of ICU mortality for PICU patients during COVID-19 Q2 increased compared with pre-COVID-19 Q2 (OR, 1.165; 95% CI, 1.00-1.357; P = .049). Interpretation Pediatric critical illness admissions decreased substantially during the second quarter of 2020, with significant changes in the types of diseases seen in PICUs in the United States. There was an increase in mortality in children admitted to the PICU during this period.Item Early Use of Adjunctive Therapies for Pediatric Acute Respiratory Distress Syndrome: A PARDIE Study(American Thoracic Society, 2020-06) Rowan, Courtney M.; Klein, Margaret J.; Hsing, Deyin Doreen; Dahmer, Mary K.; Spinella, Philip C.; Emeriaud, Guillaume; Hassinger, Amanda B.; Piñeres-Olave, Byron E.; Flori, Heidi R.; Haileselassie, Bereketeab; Lopez-Fernandez, Yolanda M.; Chima, Ranjit S.; Shein, Steven L.; Maddux, Aline B.; Lillie, Jon; Izquierdo, Ledys; Kneyber, Martin C.J.; Smith, Lincoln S.; Khemani, Robinder G.; Thomas, Neal J.; Yehya, Nadir; Pediatrics, School of MedicineRationale: Few data exist to guide early adjunctive therapy use in pediatric acute respiratory distress syndrome (PARDS).Objectives: To describe contemporary use of adjunctive therapies for early PARDS as a framework for future investigations.Methods: This was a preplanned substudy of a prospective, international, cross-sectional observational study of children with PARDS from 100 centers over 10 study weeks.Measurements and Main Results: We investigated six adjunctive therapies for PARDS: continuous neuromuscular blockade, corticosteroids, inhaled nitric oxide (iNO), prone positioning, high-frequency oscillatory ventilation (HFOV), and extracorporeal membrane oxygenation. Almost half (45%) of children with PARDS received at least one therapy. Variability was noted in the median starting oxygenation index of each therapy; corticosteroids started at the lowest oxygenation index (13.0; interquartile range, 7.6-22.0) and HFOV at the highest (25.7; interquartile range, 16.7-37.3). Continuous neuromuscular blockade was the most common, used in 31%, followed by iNO (13%), corticosteroids (10%), prone positioning (10%), HFOV (9%), and extracorporeal membrane oxygenation (3%). Steroids, iNO, and HFOV were associated with comorbidities. Prone positioning and HFOV were more common in middle-income countries and less frequently used in North America. The use of multiple ancillary therapies increased over the first 3 days of PARDS, but there was not an easily identifiable pattern of combination or order of use.Conclusions: The contemporary description of prevalence, combinations of therapies, and oxygenation threshold for which the therapies are applied is important for design of future studies. Region of the world, income, and comorbidities influence adjunctive therapy use and are important variables to include in PARDS investigations.Item Intravitreal sirolimus for persistent, exudative age-related macular degeneration: a Pilot Study(BMC, 2021-02-16) Minturn, Robert J.; Bracha, Peter; Klein, Margaret J.; Chhablani, Jay; Harless, Ashley M.; Maturi, Raj K.; Ophthalmology, School of MedicineBackground and objective: To evaluate the safety and efficacy of intravitreal sirolimus for persistent, exudative age-related macular degeneration (AMD). Methods: This institutional review board approved, registered (NCT02357342), prospective, subject-masked, single center, randomized controlled trial in subjects with persistent, exudative Age-related macular degeneration compared intravitreal sirolimus monotherapy (every 2 months) versus monthly anti-vascular endothelial growth factor (VEGF) over six months. Results: 20 subjects were randomized to each arm of the trial. Upon completion of the trial 20 patients were analyzed in the control (anti-vascular endothelial growth factor) group and 17 patients were analyzed in the treatment (sirolimus) group. On average, subjects had 33 previous anti-VEGF injections prior to entry. The primary end-point, mean central subfield thickness (CST), increased by 20 µm in the anti-vascular endothelial growth factor group and decreased by 40 µm in the sirolimus group (p = 0.03). Visual acuity outcomes were similar between groups. Serious ocular adverse events in the sirolimus group included one subject each with anterior uveitis, central retinal artery occlusion and subretinal hemorrhage. Conclusion: Monotherapy with intravitreal sirolimus for subjects with persistent, exudative age-related macular degeneration appears to have a limited positive anatomic benefit. The presence of adverse events in the experimental group merits further evaluation, potentially as an adjuvant therapy. Trial registration This trial was registered with the clinicaltrials.gov, NCT02357342, and was approved by the institutional review board at Advarra. Funding was provided by an investigator-initiated grant from Santen. Santen played no role in the design or implementation of this study.Item Mechanical power in pediatric acute respiratory distress syndrome: a PARDIE study(Springer Nature, 2022-01-03) Bhalla, Anoopindar K.; Klein, Margaret J.; Alapont, Vicent Modesto I.; Emeriaud, Guillaume; Kneyber, Martin C. J.; Medina, Alberto; Cruces, Pablo; Diaz, Franco; Takeuchi, Muneyuki; Maddux, Aline B.; Mourani, Peter M.; Camilo, Cristina; White, Benjamin R.; Yehya, Nadir; Pappachan, John; Di Nardo, Matteo; Shein, Steven; Newth, Christopher; Khemani, Robinder; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; Pediatrics, School of MedicineBackground: Mechanical power is a composite variable for energy transmitted to the respiratory system over time that may better capture risk for ventilator-induced lung injury than individual ventilator management components. We sought to evaluate if mechanical ventilation management with a high mechanical power is associated with fewer ventilator-free days (VFD) in children with pediatric acute respiratory distress syndrome (PARDS). Methods: Retrospective analysis of a prospective observational international cohort study. Results: There were 306 children from 55 pediatric intensive care units included. High mechanical power was associated with younger age, higher oxygenation index, a comorbid condition of bronchopulmonary dysplasia, higher tidal volume, higher delta pressure (peak inspiratory pressure-positive end-expiratory pressure), and higher respiratory rate. Higher mechanical power was associated with fewer 28-day VFD after controlling for confounding variables (per 0.1 J·min-1·Kg-1 Subdistribution Hazard Ratio (SHR) 0.93 (0.87, 0.98), p = 0.013). Higher mechanical power was not associated with higher intensive care unit mortality in multivariable analysis in the entire cohort (per 0.1 J·min-1·Kg-1 OR 1.12 [0.94, 1.32], p = 0.20). But was associated with higher mortality when excluding children who died due to neurologic reasons (per 0.1 J·min-1·Kg-1 OR 1.22 [1.01, 1.46], p = 0.036). In subgroup analyses by age, the association between higher mechanical power and fewer 28-day VFD remained only in children < 2-years-old (per 0.1 J·min-1·Kg-1 SHR 0.89 (0.82, 0.96), p = 0.005). Younger children were managed with lower tidal volume, higher delta pressure, higher respiratory rate, lower positive end-expiratory pressure, and higher PCO2 than older children. No individual ventilator management component mediated the effect of mechanical power on 28-day VFD. Conclusions: Higher mechanical power is associated with fewer 28-day VFDs in children with PARDS. This association is strongest in children < 2-years-old in whom there are notable differences in mechanical ventilation management. While further validation is needed, these data highlight that ventilator management is associated with outcome in children with PARDS, and there may be subgroups of children with higher potential benefit from strategies to improve lung-protective ventilation. Take home message: Higher mechanical power is associated with fewer 28-day ventilator-free days in children with pediatric acute respiratory distress syndrome. This association is strongest in children <2-years-old in whom there are notable differences in mechanical ventilation management.Item The Temporal Relationship Between Local School Closure and Increased Incidence of Pediatric Diabetic Ketoacidosis(Frontiers Media, 2022-03-11) McCluskey, Casey K.; Zee-Cheng, Janine E.; Klein, Margaret J.; Scanlon, Matthew C.; Rotta, Alexandre T.; Remy, Kenneth E.; Carroll, Christopher L.; Shein, Steven L.; Pediatrics, School of MedicineImportance: The incidence of pediatric diabetic ketoacidosis (DKA) increased early in the COVID-19 pandemic, but the relative contribution of behavioral changes and viral-related pathophysiology are unknown. Objective: To evaluate the relationship between school closure date and onset of increased DKA to help clarify the etiology of the increased incidence. Design: A multi-center, quality-controlled Pediatric Intensive Care Unit (PICU) database was used to identify the number of admissions to a participating PICU with DKA on each calendar day from 60 days before local school closure to 90 days after, and compared to baseline data from the same periods in 2018-2019. Interrupted time series and multiple linear regression analyses were used to identify admission rates that differed significantly between 2020 and baseline. Setting: Eighty-one PICUs in the United StatesParticipants: Children ages 29 days to 17 years admitted to a PICU with DKAExposures: Statewide school closureMain outcome/measure: Rate of admission to the PICU for DKA. Results: There were 1936 admissions for children with DKA in 2020 and 1795 admissions/year to those same PICUs in 2018-2019. Demographics and clinical outcomes did not differ before school closure, but pandemic-era patients were less often white and had longer hospital length of stay in the post-school closure period. The difference between 2020 admissions and 2018-2019 admissions was not different than zero before school closure, and significantly higher than zero after school closure, but was significantly increased in 2020 at >30 days after school closure (p = 0.039). Conclusions/relevance: An increase in pediatric DKA admissions began one month after school closures. Given that behavioral changes started near school closure dates and viral activity peaked weeks after, this suggests that behavioral factors may not be the primary etiology and it is possible that SARS-CoV-2 infection may have direct effects on pediatric DKA.