Observing brain oxygenation and metabolism in children with severe head injuries
Cerebral Oxygenation and Metabolism and Severe Head Injury in Paediatrics (COMetSHIP)
This study looks at how brain oxygen levels and chemistry affect recovery in children aged 3 to 16 with severe head injuries who need special monitoring in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 2 sites (Cambridge, Cambridgeshire and 1 other locations) |
| Trial ID | NCT05717647 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the factors contributing to poor outcomes in children with acute brain injuries by collecting data on intracranial pressure, brain chemistry, and oxygen levels. Special monitoring devices, routinely used in adults, will be employed to track these parameters in pediatric patients. The study will recruit children aged 3 to 16 years who require ventilation and ICP monitoring due to severe brain injuries. Data collection will occur in the Pediatric Intensive Care Unit at Addenbrooke's Hospital, focusing on understanding the ongoing brain damage that can occur after the initial injury.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 16 years who have sustained a severe brain injury and require ventilation and ICP monitoring.
Not a fit: Patients with a bleeding diathesis or those unlikely to survive more than 24 hours will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for children with severe head injuries, potentially reducing mortality and long-term disabilities.
How similar studies have performed: While similar monitoring techniques have shown success in adult populations, their application in pediatric cases is less established, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Bleeding diathesis * Patient unlikely to survive more than 24 hours
Where this trial is running
Cambridge, Cambridgeshire and 1 other locations
- Cambridge University Hospitals — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
- Cambridge University Hospitals — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Shruti Agrawal — Shruti Agrawal
- Study coordinator: Shruti Agrawal
- Email: shruti.agrawal1@nhs.net
- Phone: +44(0)1223 336946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.