• Shannon B Leland, Steven J Staffa, Margaret M Newhams, Robinder G Khemani, John C Marshall, Cameron C Young, Aline B Maddux, Mark W Hall, Scott L Weiss, Adam J Schwarz, Bria M Coates, Ronald C Sanders, Michele Kong, Neal J Thomas, Ryan A Nofziger, Melissa L Cullimore, Natasha B Halasa, Laura L Loftis, Natalie Z Cvijanovich, Jennifer E Schuster, Heidi Flori, Shira J Gertz, Janet R Hume, Samantha M Olson, Manish M Patel, David Zurakowski, Adrienne G Randolph, and Pediatric Acute Lung and Sepsis Investigator’s Network Pediatric Intensive Care Influenza Study Group (PALISI PICFLU) Investigators and Overcoming COVID-19 Investigators.
• Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, MA.
• Pediatr Crit Care Me. 2023 Dec 1; 24 (12): 9981009998-1009.

ObjectivesTo develop, evaluate, and explore the use of a pediatric ordinal score as a potential clinical trial outcome metric in children hospitalized with acute hypoxic respiratory failure caused by viral respiratory infections.DesignWe modified the World Health Organization Clinical Progression Scale for pediatric patients (CPS-Ped) and assigned CPS-Ped at admission, days 2-4, 7, and 14. We identified predictors of clinical improvement (day 14 CPS-Ped ≤ 2 or a three-point decrease) using competing risks regression and compared clinical improvement to hospital length of stay (LOS) and ventilator-free days. We estimated sample sizes (80% power) to detect a 15% clinical improvement.SettingNorth American pediatric hospitals.PatientsThree cohorts of pediatric patients with acute hypoxic respiratory failure receiving intensive care: two influenza (pediatric intensive care influenza [PICFLU], n = 263, 31 sites; PICFLU vaccine effectiveness [PICFLU-VE], n = 143, 17 sites) and one COVID-19 ( n = 237, 47 sites).InterventionsNone.Measurements And Main ResultsInvasive mechanical ventilation rates were 71.4%, 32.9%, and 37.1% for PICFLU, PICFLU-VE, and COVID-19 with less than 5% mortality for all three cohorts. Maximum CPS-Ped (0 = home at respiratory baseline to 8 = death) was positively associated with hospital LOS ( p < 0.001, all cohorts). Across the three cohorts, many patients' CPS-Ped worsened after admission (39%, 18%, and 49%), with some patients progressing to invasive mechanical ventilation or death (19%, 11%, and 17%). Despite this, greater than 76% of patients across cohorts clinically improved by day 14. Estimated sample sizes per group using CPS-Ped to detect a percentage increase in clinical improvement were feasible (influenza 15%, n = 142; 10%, n = 225; COVID-19, 15% n = 208) compared with mortality ( n > 21,000, all), and ventilator-free days (influenza 15%, n = 167).ConclusionsThe CPS-Ped can be used to describe the time course of illness and threshold for clinical improvement in hospitalized children and adolescents with acute respiratory failure from viral infections. This outcome measure could feasibly be used in clinical trials to evaluate in-hospital recovery.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.

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