Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics

NCT05688462 | Completed DMC

• 1 other identifier: ADDENBROOKESHPTBI
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

• To detect thresholds of PRx associated with favourable outcome in PTBI

  12 months

Secondary Outcomes (3)

• Characterise patterns of optimal CPP in PTBI as a function of age, severity and character of injury, intracranial pressure

  12 months

• Compare the fluctuations in these measured parameters with the outcome.

  12 months

• Establish a comprehensive paediatric database of a basic set of high resolution (pulse waveforms resolution) neuro-monitoring data including ICP, ABP and ECG

  12 months

Interventions

Data Collection OTHER

This is an observational prospective cohort study. Children admitted to ten identified PICUs in the UK with severe TBI with a clinical need for ICP and ABP monitoring will be included for data collection. The database will contain routinely monitored physiological parameters during management of PTBI in PICU. Without disturbing the routine care and management of these patients, investigators aim to collect this data continuously in a bedside laptop equipped with the study software (ICM+, Cambridge Enterprise Ltd, Cambridge, UK). Alongside these physiological parameters, investigators will also collect relevant clinical and demographic data (details below) and follow these patients for up to 12 months post ictus to assess neuro-psychological outcome.

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children upto the age of 16 years with TBI identified on CT/MRI with a clinical need for invasive blood pressure and intracranial pressure monitoring

You may qualify if:

• Patients 16 years old or younger at the time of injury
• Admitted to PICU for management of TBI
• TBI-related pathology confirmed on CT or MRI
• Clinical requirement for invasive monitoring of ICP and ABP

You may not qualify if:

• \- None

Sponsors & Collaborators

• Shruti Agrawal: lead
• Action Medical Research: collaborator

Study Sites (1)

Shruti Agrawal

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (2)

• Agrawal S, Smith C, Bogli SY, Placek MM, Cabeleira M, White D, Daubney E, Young A, Beqiri E, Kayani R, O'Donnell D, Pathan N, Watson S, Maw A, Ganrett M, Kanthimathinathan HK, Bangalore H, Sundararajan S, Subramanian G, Raffaj D, Sarfatti A, Lampareillo S, Mayer A, Ross O, Czosnyka M, Hutchinson PJ, Smielewski P; STARSHIP study team. Status of cerebrovascular autoregulation relates to outcome in severe paediatric head injury: STARSHIP, a prospective multicentre validation study. EClinicalMedicine. 2025 Feb 5;81:103077. doi: 10.1016/j.eclinm.2025.103077. eCollection 2025 Mar.

  PMID: 39996125 BACKGROUND

• Agrawal S, Placek MM, White D, Daubney E, Cabeleira M, Smielewski P, Czosnyka M, Young A, Watson S, Maw A, Hutchinson PJ. 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. BMJ Open. 2023 Mar 10;13(3):e071800. doi: 10.1136/bmjopen-2023-071800.

  PMID: 36898758 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Shruti Agrawal, MD

  Cambridge University Hospitals Nhs Foundation Trust - Cambridge, Cambridgeshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant PIC

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: July 1, 2018
• Primary Completion: April 30, 2024
• Study Completion: March 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)