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ACTIVE NOT RECRUITING
NCT07538440

Prognostic Model for Predicting Outcome After Moderate to Severe Paediatric Traumatic Brain Injury

Sponsor: Cambridge University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

Summary

Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for managing paediatric traumatic brain injury (pTBI). The prognostic models used for adult TBI research (IMPACT, CRASH), have been derived and validated from analysis of large international datasets which have undergone further validation in multiple prospective studies; the wide use of these prognostic models across neurotrauma research highlights the relative simplicity and the variables used for prediction making them applicable to both low and high resource set-ups. This has facilitated international collaborative research in adult TBI. At present, no such models exist for pTBI with most paediatric research continuing to use adult prognostic models. Though the variables used for these models show association with outcome in pTBI as well, there are multiple issues with this approach with the key difficulty being that younger age is expected to be associated with better outcome in these models; however, the balance between neuroplasticity and neurodevelopmental trajectory in children is difficult to predict with evidence suggesting worse neuro-developmental outcomes after TBI in younger children. Hence the adult models can either over- or under-predict neurological outcomes in pTBI and have never been validated in pTBI datasets. Given that the amount of data required to create pTBI predictive model is difficult to collect and reasonable validity of adult prognostic models in pTBI, investigators propose to create paediatric modification to the adult models and identify a robust pTBI predictive model for improved classification of injury severity to predict disease trajectory and outcome as well as stratification of patients for interventional research and benchmarking in pTBI to help with appropriate resource allocation for neuro-interventions towards improved outcomes. This will help identify age-appropriate benchmarks for pTBI research studies as well as complement an individual child's clinical assessment, treatment decisions, informing families and resource allocation.

Official title: Prediction Model in Paediatric Moderate to Severe TBI

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2025-07-01

Completion Date

2026-12

Last Updated

2026-04-22

Healthy Volunteers

No

Locations (1)

Hospital

Cambridge, Cambridgeshire, United Kingdom