All studies
Not yet recruitingNAINTERVENTIONAL

Advanced MRI in IVH

Every year, thousands of babies are born too early in the UK. Some of these babies can have bleeding in their brain, which can lead to fluid build-up and sometimes long-term problems. Currently, doctors drain this fluid to reduce pressure. This study is testing a new operation that not only drains fluid but also washes out the blood from the brain. We want to see if this 'washout' procedure helps babies more than just draining the fluid. We're also using new, advanced MRI scans to get a better look at the baby's brain. These scans will help us understand how the washout procedure works, how babies' brains are affected, and if they can predict a baby’s future development and treatment needs.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Enrolment target
30
Start
16 Feb 2026
Estimated completion
01 May 2027

What is this study about?

When babies are born very early, their brains are still developing and can be quite delicate. Sometimes, tiny blood vessels can break in the brain's fluid-filled spaces, called ventricles. This bleeding is serious and can eventually cause too much fluid to build up in the brain, a condition called hydrocephalus. This extra fluid can put pressure on the brain and can cause problems with a baby's development.

At the moment, the usual treatment for this fluid build-up is to drain the excess fluid to relieve the pressure. However, researchers have found that the blood itself and what it breaks down into can be harmful to the developing brain. Following promising early results, doctors at Great Ormond Street Hospital (GOSH) have developed an operation that not only drains this fluid but also gently washes out the harmful blood from the brain using a tiny camera and tools (called an endoscope). This study wants to compare this new 'washout' treatment with the standard fluid drainage treatment to see which is more helpful for babies.

We will also be using very advanced MRI scans for babies in this study at GOSH and Alder Hey Children's Hospital. These special scans will help us get a much more detailed picture of the brain's structure, how it works, and how fluids are flowing. By looking closely at these scans, we hope to understand how the washout procedure (if a baby has it) affects the brain. We also want to see if these new scans can give us better clues about how babies might develop later on and what kind of support they might need. If these new scanning methods prove useful, the aim is to use them more widely in the NHS to help more babies.

Key takeaways

  • Looks at new, advanced MRI scans for premature babies with brain bleeding.
  • Aims to understand the impact of a 'washout' operation on the brain.
  • Hopes to better predict future development and treatment needs.
  • Involves a special MRI scan around the baby's original due date.
  • Takes place at Great Ormond Street Hospital or Alder Hey Children's Hospital.
  • Information gained could improve future care for many babies.

Who may be eligible?

This study is looking for premature babies who have bleeding in their brain followed by fluid build-up and who are receiving special brain surgery at Great Ormond Street Hospital (GOSH) or Alder Hey Children's Hospital.

Most of the babies in this study will also be taking part in a larger study called ENLIVEN-UK, which is comparing the washout procedure with standard treatment. Being in the ENLIVEN-UK study does not stop a baby from being included in this advanced MRI study.

To be included, parents or guardians must give their permission for their baby to take part. If a parent or guardian doesn't feel comfortable giving consent, their baby won't be included in this 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.

  1. Is my baby premature?
  2. Has my baby had bleeding in their brain (intraventricular haemorrhage)?
  3. Is my baby considering or already having brain surgery for fluid build-up?
  4. Is my baby being cared for at Great Ormond Street Hospital (GOSH) or Alder Hey Children's Hospital?
  5. Am I comfortable giving permission for my baby to take part?
Answer every question to see your result.

What does participation involve?

If your baby is taking part in this study, they will have special, more detailed MRI scans of their brain. This scan will happen around the time your baby was originally due to be born. It will take place at either Great Ormond Street Hospital (GOSH) or Alder Hey Children's Hospital. Your baby will have their usual routine MRI scan, and during the same appointment, some additional, newer scanning techniques will be used. These extra scans don't involve any additional procedures for your baby, only more detailed images collected at the same time.

Your baby's doctors will monitor their health and development as part of their ongoing care, and as part of the wider ENLIVEN-UK trial if they are in that study too. Information from these check-ups, especially around 2 years of age, will be looked at alongside the MRI scan results to understand how the brain changes relate to their development.

Potential risks and benefits

Taking part in this study might offer a better understanding of your baby's brain and how treatments affect it, which could help guide their future care. The advanced MRI scans are non-invasive and do not involve any radiation, making them generally safe. However, as with any medical procedure, there's always a very small risk, such as needing sedation to keep a baby still for the scan, though this is carefully managed. The most important benefit is that the information gained could improve care for many other premature babies in the future. Remember, you can decide to withdraw your baby from the study at any time without it affecting their medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alder Hey Children's Hospital
    Verified postcode
    Liverpool, United Kingdom
  • Great Ormond Street Hospital for Children
    Verified postcode
    London, United Kingdom

Common questions

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of the body, including the brain. It doesn't use X-rays or radiation.

Why are these MRI scans 'advanced'?

These scans use special techniques that can show much more detail about the brain's structure, how different parts connect, and how fluids flow around the brain, beyond what a standard MRI can achieve.

Will my baby get different treatment if they are in this study?

This study is primarily about the advanced MRI scans. If your baby is also in the ENLIVEN-UK trial, they might receive either the standard fluid drainage or the new 'washout' procedure, as decided by that study. This particular MRI study doesn't change the treatment they receive.

What happens if the advanced MRI scans find something new in my baby's brain?

The images will be reviewed by experts. Any findings that might impact your baby's care would be discussed with your medical team, just like with any other scan.

How long will the MRI scan take?

The scan time will be agreed with your medical team. Your baby will need to remain still for the scan, and sometimes gentle sedation is used to help with this in very young babies.

How to find out more

Kristian Aquilina, PhD, FRCS (SN)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Advanced MRI in IVH…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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