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.

Síndrome inflamatorio multisistémico en niños asociado a infección por SARS-CoV-2 / Multisystemic inflammatory syndrome in children associated with SARS-CoV-2 infection

El siguiente reporte de caso describe la presentación del síndrome inflamatorio multisistémico asociado a la infección por el coronavirus 2 del síndrome respiratorio agudo grave (SARS-CoV-2 por sus siglas en inglés) en niños, que inicialmente se comparó con el síndrome mucocutáneo linfonodular, mejor conocido como enfermedad de Kawasaki clásica. Sin embargo, existen marcadas diferencias entre ambos síndromes, como se observará en el desarrollo del caso clínico, el cual cursa con un importante compromiso pulmonar, desarrollando un síndrome de distress respiratorio agudo pediátrico y posteriormente secuelas cardiovasculares que determinan el desenlace desfavorable. En este caso, la paciente desarrolló las manifestaciones de gravedad al sexto día de enfermedad y se inició cuidados intensivos oportunos con soporte aminérgico, ventilación con maniobras de protección alveolar e inicio temprano de inmunoglobulinas, lo que permitió el destete progresivo de todas las medidas instauradas. Así como se obtuvieron aciertos en el manejo intensivo, otros aspectos de la terapéutica se van dejando de lado con el mayor conocimiento de esta entidad y su reconocimiento temprano

The following case report describes the presentation of the multisystemic inflammatory syndrome associated with infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in children, which was initially compared with lymphonodular mucocutaneous syndrome, better known as classic Kawasaki disease. However, there are marked differences between both syndromes, as will be observed in the development of the clinical case, which presents with significant pulmonary involvement, developing a pediatric acute respiratory distress syndrome and later cardiovascular sequelae that determine the unfavorable outcome. In this case, the patient developed the manifestations of severity on the sixth day of the disease and timely intensive care with aminergic support, ventilation with alveolar protection maneuvers and early initiation of immunoglobulins was started, which allowed progressive weaning of all the measures established. As well as successes were obtained in the intensive management, other aspects of the therapy are being put aside with the greater knowledge of this entity and its early recognition