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. 2024 Jan 1;94(1):65-71.
doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.

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

Randall Chesnut  1   2   3   4 , Nancy Temkin  1   5 , James Pridgeon  1 , Stephen Sulzbacher  6 , Silvia Lujan  7   8 , Walter Videtta  9 , Luis Moya-Barquín  10 , Kelley Chaddock  1 , Robert Bonow  1 , Gustavo Petroni  7   8 , Nahuel Guadagnoli  7   8 , Peter Hendrickson  1 , Grimaldo Ramírez Cortez  11 , Nilton Yhuri Carreazo  11   12 , Alcides Vargas Aymituma  11 , Daniel Anchante  13 , Patrick Caqui  13 , Alberto Ramírez  13 , Manuel Munaico Abanto  14 , Manuel Ortiz Chicchon  14 , José Cenzano Ramos  14 , Analy Mazate-Mazariegos  10 , María Del Carmen Castro Darce  10 , Roberto Sierra Morales  10 , Pedro Brol Lopez  10 , Willy Menendez  15 , Sofía Posadas Gutierrez  15 , Vicente Kevin  15 , Andrea Mazariegos  16 , Elie de Leon  16 , Rodolfo Enrique Rodas Barrios  16 , Sandra Rodríguez  17 , Sandra Flores  17 , Ovidio Alvarado  17 , Luis José Guzman Flores  18 , Melvin Moisa Martinez  18 , Pablo Gonzalez  18
Affiliations

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

Randall Chesnut et al. Neurosurgery. .

Abstract

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.

Trial registration: ClinicalTrials.gov NCT05566431.

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Original study timeline.
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References

    1. Coronado VG, Xu L, Basavaraju SV, et al. Surveillance for traumatic brain injury-related deaths—United States, 1997-2007. MMWR Surveill Summ. 2011;60(5):1-32. - PubMed
    1. Kassebaum N, Kyu HH, Zoeckler L, et al. Child and adolescent health from 1990 to 2015: findings from the global burden of diseases, injuries, and risk factors 2015 study. JAMA Pediatr. 2017;171(6):573-592. - PMC - PubMed
    1. Bartlett SN. The problem of children's injuries in low-income countries: a review. Health Policy Plan. 2002;17(1):1-13. - PubMed
    1. Kochanek PM, Tasker RC, Bell MJ, et al. Management of pediatric severe traumatic brain injury: 2019 consensus and guidelines-based algorithm for first and second tier therapies. Pediatr Crit Care Med. 2019;20(3):269-279. - PubMed
    1. Kochanek PM, Tasker RC, Carney N, et al. Guidelines for the management of pediatric severe traumatic brain injury, third edition: update of the brain trauma foundation guidelines. Pediatr Crit Care Med. 2019;20(3S suppl 1):s1–s82. - PubMed

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