Age Related Thresholds for Management of Severe Head Injury in Paediatrics: An Extension of STARSHIP

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 450
• From 1 Mar 2026 to the primary completion date, Sept 2028
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who the study is looking for

Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers

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Sites (1)

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