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.

Taponamiento cardíaco y hemorragia intracerebral en un niño con la COVID-19: Reporte de un Caso / Cardiac Tamponade And Intracranial Hemorrhage In A COVID-19 Pediatric Patient: Case Report

La enfermedad por coronavirus 2019 (COVID-19) es una pandemia según declaraciones de la Organización Mundial de la Salud. Afecta tanto a la población adulta como pediátrica; sin embargo, la mayor información publicada corresponde a los primeros, generando una brecha de conocimiento con respecto a los niños. El compromiso pulmonar parece ser la manifestación más frecuente de la enfermedad, aunque se han reportado afecciones extrapulmonares como derrame pericárdico y enfermedades cerebrovasculares en adultos; sin embargo, según nuestra revisión ninguna ha sido reportada en niños. Presentamos el caso de un paciente varón de 7 años con antecedentes de asma y sobrepeso que presentó la COVID-19, fue hospitalizado a través del servicio de emergencia por neumonía y evolucionó con insuficiencia respiratoria que requirió soporte ventilatorio invasivo. Durante su hospitalización presentó taponamiento cardiaco y hemorragia intracerebral con evolución desfavorable y desenlace fatal.

The new coronavirus disease (COVID-19) is actually a pandemic according to the World Health Organization. It affects both the adult and pediatric population, however the most published information correspond to the first one, generating a knowledge gap regarding children. Pulmonary involvement appears to be the most frequently manifestation of the disease, although extrapulmonary complications such as pericardial effusion and cerebrovascular diseases have been reported in adults, and according to our review none have been reported in children. We present a case of a 7 year old patient with previous history of asthma and overweight that present COVID-19, and was admitted through the pediatric emergency department for pneumonia and developed a respiratory failure that requires ventilatory support. During its hospitalization presents cardiac tamponade and intracerebral hemorrhage with adverse evolution and fatal outcome.