Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol.

BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI. METHODS: A phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-appropriate Glasgow Coma Scale score ≤8) randomized to ICP-based or non-ICP-based management. EXPECTED OUTCOMES: Primary outcome is 6-month Pediatric Quality of Life. Secondary outcomes are 3-month Pediatric Quality of Life, mortality, 3-month and 6-month Pediatric extended Glasgow Outcome Score, intensive care unit length of stay, and number of interventions focused on treating measured or suspected intracranial hypertension. DISCUSSION: This is not a study of the value of knowing the ICP in sTBI. This research question is protocol-based. We are investigating the added value of protocolized ICP management to treatment based on imaging and clinical examination in the global population of severe pediatric TBI. Demonstrating efficacy should standardize ICP monitoring in severe pediatric TBI. Alternate results should prompt reassessment of how and in which patients ICP data should be applied in neurotrauma care.

Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms.

BACKGROUND AND OBJECTIVES: The efficacy of our current approach to incorporating intracranial pressure (ICP) data into pediatric severe traumatic brain injury (sTBI) management is incompletely understood, lacking data from multicenter, prospective, randomized studies. The National Institutes of Health-supported Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial will compare outcomes from pediatric sTBI of a management protocol based on ICP monitoring vs 1 based on imaging and clinical examination without monitoring. Because no applicable comprehensive management algorithms for either cohort are available, it was necessary to develop them. METHODS: A consensus conference involving the 21 intensivists and neurosurgeons from the 8 trial sites used Delphi-based methodology to formulate management algorithms for both study cohorts. We included recommendations from the latest Brain Trauma Foundation pediatric sTBI guidelines and the consensus-based adult algorithms (Seattle International Brain Injury Consensus Conference/Consensus Revised Imaging and Clinical Examination) wherever relevant. We used a consensus threshold of 80%. RESULTS: We developed comprehensive management algorithms for monitored and nonmonitored cohort children with sTBI. We defined suspected intracranial hypertension for the nonmonitored group, set minimum number and timing of computed tomography scans, specified minimal age-adjusted mean arterial pressure and cerebral perfusion pressure targets, defined clinical neuroworsening, described minimal requisites for intensive care unit management, produced tiered management algorithms for both groups, and listed treatments not routinely used. CONCLUSION: We will study these protocols in the Benchmark Evidence from Latin America-Treatment of Raised Intracranial Pressure-Pediatrics trial in low- and middle-income countries. Second, we present them here for consideration as prototype pediatric sTBI management algorithms in the absence of published alternatives, acknowledging their limited evidentiary status. Therefore, herein, we describe our study design only, not recommended treatment protocols.

Rabdomiólisis severa en un lactante con síndrome inflamatorio multisistémico asociado a covid -19 (mis-c)

Introducción: un caso de rabdomiólisis severa asociado a síndrome inflamatorio multisistémico asociado a COVID -19 (MIS-C). Reporte de caso: en un niño de 1 año 10 meses que presentó síntomas digestivos, mialgias, debilidad, fiebre y orina oscura. Prueba serológica COVID-19 IgM (-) IgG (+), PCR COVID-19 negativo. Creatin-quinasa (CK) inicial fue no dosable, siendo el nivel reportado más alto de 517 600 U/L. El valor de creatinina se mantuvo normal durante toda la hospitalización. Recibió Inmunoglobulina humana 2 g/Kg, Metilprednisolona 10 mg/Kg/d y ácido acetil salicílico para manejo de MIS-C. Se brindó hidratación enérgica y alcalinización de orina para manejo de rabdomiólisis. Conclusión: Evolución favorable con alta luego de diez días. Existen pocos casos reportados de rabdomiólisis asociados a MIS-C, y ninguno con valores tan altos de CK. En base a las posibles complicaciones se sugiere realizar dosaje de CK de forma rutinaria en todos los pacientes con MIS-C.

Introduction: A case of severe rhabdomyolysis associated with multisystem inflammatory syndrome related to COVID-19 (MIS-C). Case of report: is presented in a one-year 10-month-old boy who presented digestive symptoms, myalgia, weakness, fever, and dark urine. COVID-19 IgM (-) IgG (+) serological test, COVID-19 PCR negative. Initial creatine kinase (CK) presented non-dosable values, with the highest reported level being 517,600 U/L. The creatinine value remained normal throughout the hospitalization. He received human immunoglobulin 2 g/Kg, Methylprednisolone 10 mg/Kg/d, and acetylsalicylic acid to manage MIS-C. Aggressive hydration and urine alkalinization were provided to manage rhabdomyolysis. Conclusion: Positive evolution with discharge after ten days. Few reported cases of rhabdomyolysis are associated with MIS-C and none with such high CK values. Based on the possible complications, performing CK dosing in all patients with MIS-C is suggested routinely.