Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics (STARSHIP): protocol to study cerebral autoregulation in a prospective multicentre observational research database study.

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Placek, Michal M 
White, Deborah 
Daubney, Esther 
Cabeleira, Manuel 

INTRODUCTION: Studying cerebral autoregulation, particularly PRx (Pressure Reactivity Index), is commonly employed in adult traumatic brain injury (TBI) and gives real-time information about intracranial pathophysiology, which can help in patient management. Experience in paediatric TBI (PTBI) is limited to single-centre studies despite disproportionately higher incidence of morbidity and mortality in PTBI than in adult TBI. PROJECT: We describe the protocol to study cerebral autoregulation using PRx in PTBI. The project called Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics is a multicentre prospective ethics approved research database study from 10 centres across the UK. Recruitment started in July 2018 with financial support from local/national charities (Action Medical Research for Children, UK). METHODS AND ANALYSIS: The first phase of the project is powered to detect optimal thresholds of PRx associated with favourable outcome in PTBI by recruiting 135 patients (initial target of 3 years which has changed to 5 years due to delays related to COVID-19 pandemic) from 10 centres in the UK with outcome follow-up to 1-year postictus. The secondary objectives are to characterise patterns of optimal cerebral perfusion pressure in PTBI and compare the fluctuations in these measured parameters with outcome. The goal is to create a comprehensive research database of a basic set of high-resolution (full waveforms resolution) neuromonitoring data in PTBI for scientific use. ETHICS AND DISSEMINATION: Favourable ethical approval has been provided by Health Research Authority, Southwest-Central Bristol Research Ethics Committee (Ref: 18/SW/0053). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05688462.

neurological injury, paediatric intensive & critical care, physiology, trauma management, Adult, Child, Humans, Brain Injuries, Traumatic, Cerebrovascular Circulation, COVID-19, Homeostasis, Intracranial Pressure, Multicenter Studies as Topic, Observational Studies as Topic, Pandemics, Prospective Studies
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BMJ Open
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Action Medical Research (via Cambridge University Hospitals NHS Foundation Trust (CUH)) (GN2609)
Action Medical Research for Children’s Charity, UK (grant number- GN2609). Cambridge University Hospitals is the study sponsor (reference: A094693, contact person: Michelle Ellerbeck-