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

Study acronym: PROMPT
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Dec 31, 2026
See other at-risk trials from Cambridge University Hospitals NHS Foundation Trust

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion pushed from Jul 2026 to Dec 31, 2026 Show 4 more changesShow less
    • Study completion date: Dec 2026 to Dec 31, 2026
    • Publications: details revised at 9 of 9 entries
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 5 words
  2. Minor Primary endpoint revised
    • Study description shortened, about 23 words
    • Study title revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07538440
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators: UMC Utrecht
Conditions
(from sponsor)
Traumatic Brain Injury (TBI)
Related terms Brain Injuries, Traumatic
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov