Active not recruitingOBSERVATIONAL

Cerebral Oxygenation and Metabolism and Severe Head Injury in Paediatrics (COMetSHIP)

This study, called COMetSHIP, is investigating why some children with severe head injuries have worse outcomes. Researchers are collecting information on how the brain’s oxygen levels and chemical changes affect recovery. While regular monitoring of pressure inside the head is common, this study plans to use additional monitors to get a clearer picture of what's happening in the brain. These special monitors are already used safely in adults, and the study hopes to show how they could help improve the care for children with serious head injuries by giving doctors more information to guide treatment.

At a glance

Status

Active not recruiting

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

01 Jul 2023

Estimated completion

31 Oct 2029

Traumatic Brain Injury

What is this study about?

This study, called COMetSHIP (which stands for Cerebral Oxygenation and Metabolism and Severe Head Injury in Paediatrics), is focused on understanding and improving the care for children who have suffered a severe head injury. Doctors know that a lot of the damage to the brain that can lead to long-term problems often happens in the hours and days after the initial injury. This damage can be due to factors like swelling in the brain or not enough oxygen reaching the brain tissue.

Currently, one of the main ways doctors look after children with head injuries is by monitoring the pressure inside their heads. However, this doesn't tell the whole story about what's going on in the brain. This study wants to explore additional ways of monitoring the brain, such as checking oxygen levels and chemical changes directly within the brain tissue. These types of advanced monitors are safely used in adults, but haven't been widely used in children yet. By gathering this extra information, the researchers hope to learn more about how brain injuries affect children and how best to protect their brains during recovery.

The overall goal is to find out what factors contribute to poor recovery so that doctors can refine their treatment approaches. This could lead to better outcomes for children who experience a severe head injury in the future, helping them to recover as fully as possible.

Key takeaways

Looks at severe head injuries in children.
Observes brain oxygen and chemical changes.
Aims to understand causes of delayed brain damage.
Uses advanced monitors, safely used in adults.
Could help improve future care for children.
For children aged 3 to 16 in intensive care.

Who may be eligible?

This study is designed for children who have had a very serious head injury and need to be in intensive care. Specifically, they need to be on a breathing machine (ventilator) and require monitoring of the pressure inside their head.

To be considered for the study, children must be between 3 and 16 years old. Children younger than 3 are not included because the specific type of monitoring equipment used in this study isn't generally used for very young children.

Some children might not be suitable for the study. For example, if a child has a significant bleeding disorder, they wouldn't be able to take part. Also, if a child's doctors don't expect them to survive for more than 24 hours, they wouldn't be included in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is the child currently in intensive care for a severe head injury?
Is the child on a breathing machine (ventilator)?
Is the child between 3 and 16 years old?
Does the child need monitoring for pressure inside their head?
Does the child NOT have a significant bleeding disorder?
Is it expected that the child will survive for more than 24 hours?

Answer every question to see your result.

What does participation involve?

This is an 'observational' study, which means researchers will be gathering information about what's already happening as part of the child's care, rather than giving new treatments. Children will be in the Paediatric Intensive Care Unit at Addenbrooke's Hospital. As part of their routine care for a severe brain injury, special monitors are often placed in the head to check pressure and oxygen levels in the brain. For this study, an additional small monitor that tracks chemical changes in the brain will also be used. This extra monitor is placed using the same small opening where the other monitors go, so no extra procedure is needed.

The fluid collected by this chemical monitor is checked at the bedside, and any leftover fluid is stored for further analysis to look for signs of inflammation. Because of the nature of their injury and needing sedation, children won't be aware of being part of the study. Initially, consent for data collection won't be sought, as this allows researchers to get a clear and unbiased view of what happens in all similar patients. This approach has been approved by ethics committees for similar studies in the UK.

Potential risks and benefits

This is an observational study, meaning it doesn't involve giving new treatments or medications. The monitoring devices used, including the one for chemical changes, are either already part of routine care for severe head injuries or are safely used in adults with similar conditions. No additional surgical procedures are required for the study's extra monitor. The main potential benefit is that the information gathered could help doctors improve how they treat children with severe head injuries in the future, leading to better recovery rates. There are no additional direct risks to the child from participating beyond the risks already associated with their critical condition and necessary medical monitoring. Families will be fully informed when their child is stable, and you would have the right to withdraw your child's data from the study at any point.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge University Hospitals
Verified postcode
Cambridge, United Kingdom
Cambridge University Hospitals
Verified postcode
Cambridge, United Kingdom

Common questions

What is the main goal of this study?

The study aims to understand what causes ongoing brain damage after a severe head injury in children, to help improve future treatments and outcomes.

Will my child receive new treatments as part of this study?

No, this is an observational study. Your child will receive standard care, and researchers will simply gather information from their monitoring equipment.

What kind of monitoring is involved?

Besides standard brain pressure and oxygen monitoring, a small extra sensor will be used to check chemical changes in the brain, without any extra procedures.

How old do children need to be to join?

Children between 3 and 16 years old can be included in this study.

Can I remove my child's data from the study?

Yes, once your child is stable and you've been informed, you have the right to withdraw their data from the study at any time.