Clinical trial · Observational
Age Related Thresholds for Management of Severe Head Injury in Paediatrics: An Extension of STARSHIP
Age Related Thresholds For Management Of Severe Head Injury In Paediatrics: ARTSHIP
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Traumatic brain injury in children can cause serious and long-lasting neuro-disability. However, there is still limited evidence about the best ways to treat children with severe brain injury in intensive care. One important part of treatment is managing pressure inside the skull and ensuring that the brain receives enough blood and oxygen. Current international guidelines provide treatment targets, but these recommendations are based on relatively limited research in children. This is particularly challenging because children range from infants to teenagers, and the developing brain changes considerably with age. A single treatment target may therefore not be appropriate for every child. Carrying out large clinical trials in critically ill children is difficult for both practical and ethical reasons. An alternative approach is to combine information that is already being collected during routine intensive care and use these large datasets to better understand which treatments may be most helpful. Investigator's previous multicentre study, STARSHIP (Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics), collected detailed information from 135 children with traumatic brain injury. The study combined clinical information with continuous measurements of brain-related physiology. One of these measurements, called the pressure reactivity index (PRx), provides information about how well the brain is able to regulate its own blood supply. Investigators found that PRx was associated with patient outcomes, regardless of the initial severity of the injury, and that treatment practices varying between hospitals. Investigators also found that changes in PRx over time may provide useful information about recovery and outcome. The STARSHIP study has created a valuable research database that allows us to explore how measurements such as pressure inside the skull, blood flow to the brain, and the brain's ability to regulate its blood supply relate to recovery. However, there were not enough children within each age group to determine whether different treatment targets should be used for infants, younger children, and teenagers. Several hospitals in the United Kingdom (UK) and internationally have collected similar detailed information. Through this project, these centres will work together to combine their existing datasets, creating a much larger group of approximately 350-500 children with traumatic brain injury. By analysing this larger dataset, investigators hope to identify treatment targets that are more appropriate for children of different ages. In particular, they will study pressure inside the skull, blood pressure supplying the brain, and the brain's ability to regulate its own blood flow. Ultimately, this research could help doctors move away from a "one-size-fits-all" approach and towards more personalised treatment for children with severe traumatic brain injury. By identifying age-appropriate and patient-specific treatment targets, investigators hope to improve brain protection and, ultimately, outcomes for injured children.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Autoregulation | — | UNRESOLVED | — |
| Cerebral Perfusion Pressure | — | UNRESOLVED | — |
| Intracranial Pressure | — | UNRESOLVED | — |
| Pediatric | — | UNRESOLVED | — |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (7)
- label
- STARSHIP
- description
- Research Database
- label
- Cambridge
- description
- Cambridge pTBI patients cohort
- label
- BIrmingham
- description
- Birmingham pTBI patients cohort
- label
- Uppasala
- description
- Uppasala pTBI patients cohort
- label
- Leuven
- description
- Leuven pTBI patients cohort
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Datasets will be eligible if they contain at least 15 children with TBI and include: 1. patients younger than 18 years at the time of injury; 2. invasive advanced neuromonitoring including ICP and ABP; 3. high-resolution physiologic waveform data, preferably sampled at 100 Hz or greater; 4. at least 6 hours of analyzable physiologic recording per patient; 5. sufficient demographic and clinical information to characterize TBI severity; and 6. functional outcome assessment approximately 6 months after injury. Twelve-month outcome information will also be included where available. Exclusion Criteria: None \-
References
Publications (4)
- BACKGROUNDSorrentino E, Diedler J, Kasprowicz M, Budohoski KP, Haubrich C, Smielewski P, Outtrim JG, Manktelow A, Hutchinson PJ, Pickard JD, Menon DK, Czosnyka M. Critical thresholds for cerebrovascular reactivity after traumatic brain injury. Neurocrit Care. 2012 Apr;16(2):258-66. doi: 10.1007/s12028-011-9630-8. PMID 21964774
- BACKGROUNDAgrawal 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
- BACKGROUNDKochanek PM, Tasker RC, Carney N, Totten AM, Adelson PD, Selden NR, Davis-O'Reilly C, Hart EL, Bell MJ, Bratton SL, Grant GA, Kissoon N, Reuter-Rice KE, Vavilala MS, Wainwright MS. Guidelines for the Management of Pediatric Severe Traumatic Brain Injury, Third Edition: Update of the Brain Trauma Foundation Guidelines. Pediatr Crit Care Med. 2019 Mar;20(3S Suppl 1):S1-S82. doi: 10.1097/PCC.0000000000001735. No abstract available. PMID 30829890
- BACKGROUNDDewan MC, Mummareddy N, Wellons JC 3rd, Bonfield CM. Epidemiology of Global Pediatric Traumatic Brain Injury: Qualitative Review. World Neurosurg. 2016 Jul;91:497-509.e1. doi: 10.1016/j.wneu.2016.03.045. Epub 2016 Mar 25. PMID 27018009