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Recruiting
NCT05688462
Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics
Conditions: TBI (Traumatic Brain Injury)
Sex: All
Ages: 3 Months – 16 Years
Enrollment: 135
Sponsor: Shruti Agrawal
Location: United Kingdom
Summary
Children are known to have devastating impact from traumatic brain injury (TBI).
The focus of treatment of severe TBI is to limit secondary insult which can aggravate brain injury and worsen outcome and is supported by monitoring brain pressure (ICP) and arterial pressure (ABP).
These pressures, if incorporated in Multi-modality monitoring can be used to interpret state of mechanisms used by brain to maintain normal blood flow.
This has been advised to guide management of severe TBI in adults, however, there is limited experience with advanced brain monitoring in children.
The investigators propose to study the use of this in children with severe TBI.
Children (up to 16 years of age) with a severe TBI are referred to a neurosurgical unit (NSU) and admitted to a paediatric intensive care unit (PICU) as part of usual NHS clinical practice.
All patients with a severe TBI require a monitoring wire to be inserted into the brain to read the pressure inside the skull and a similar device in an artery to monitor the blood pressure.
These recordings are documented by a PICU nurse at a prescribed frequency.
Without interrupting this clinical practice investigators propose to record these values using computer software called ICM+.
These recordings will provide real time analysis and a continual recording of important parameters which will provide the study with much needed information on the patterns of pressures in the brain after this injury in children.
All patients will be followed up for 12 months to see how well they recover, neuropsychology assessment will be performed by a Neuropsychologist at the recruiting centre using a standardised form.
Eligibility Criteria
Inclusion Criteria:Patients 16 years old or younger at the time of injuryAdmitted to PICU for management of TBITBI-related pathology confirmed on CT or MRIClinical requirement for invasive monitoring of ICP and ABPExclusion Criteria:- None
Source: ClinicalTrials.gov (NCT05688462). StuddyBuddy aggregates publicly available trial information.