NCT05717647

Brief Summary

Children suffer proportionally more head injuries than any other age group and children with head injuries have the highest mortality of all children admitted with traumatic injuries. The investigators aim to investigate the factors that contribute to poor outcomes after paediatric acute brain injury by collecting observational and outcome data. Much of the brain damage that results in poor outcomes actually happens in the hours and days after the injury. This is due to several factors such as brain swelling and poor oxygen delivery to the brain. Treatment is directed to try and protect the brain against these factors. Current management of the head injured child focuses on monitoring pressure within the head. However, this does not detect all the factors that cause continuing brain damage. Special monitors that follow oxygen levels and chemical changes in the brain are used safely in adult patients but have not been widely employed in children despite their potential benefit. There is therefore the opportunity to evaluate extra monitoring of the child brain, and in doing so, help refine the management of these patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
42mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Jul 2023Oct 2029

First Submitted

Initial submission to the registry

May 16, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

May 16, 2022

Last Update Submit

September 29, 2025

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Death at 30 days

    30 days

  • Mortality

    Death at 12 months

    12 months

Secondary Outcomes (4)

  • PedsQL

    6 and 12 months

  • Functional outcomes

    6 and 12 months

  • Correlation of lactate to pyruvate ratio (LPR) with intracranial pressure, cerebral perfusion pressure and brain tissue oxygenation

    End of Neuro-monitoring period (upto 2 weeks)

  • Functional outcomes in relation to LPR

    6 and 12 months

Study Arms (1)

Paediatric patients with severe traumatic brain injury undergoing multimodality monitoring

* Patients admitted with brain injury requiring ventilation and ICP monitoring * Age group: 3 years and 16 years (children under the age of three years are excluded as the triple bolt for multimodality monitoring is not currently used for this age group)

Other: Observational study: neuromonitoring

Interventions

Observational study: neuromonitoringOTHER

collection of multimodality neuromonitoring data including ICP, brain tissue oxygen tension, cerebral microdialysis data

Paediatric patients with severe traumatic brain injury undergoing multimodality monitoring

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients with severe brain injury undergoing multimodality neuromonitoring

You may qualify if:

  • Patients admitted with brain injury requiring ventilation and ICP monitoring
  • Age group: 3 years and 16 years (children under the age of three years are excluded as the triple bolt for multimodality monitoring is not currently used for this age group)

You may not qualify if:

  • Bleeding diathesis
  • Patient unlikely to survive more than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cambridge University Hospitals

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Cambridge University Hospitals

Cambridge, Cambridgeshire, CB2 9AS, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Shruti Agrawal

    Shruti Agrawal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2022

First Posted

February 8, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2029

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

GB(2)