AuthorisedTherapeutic use (Phase IV)Interventional

Contrast enhanced ultrasound and elastography of the neonatal brain

This important study is exploring new ultrasound techniques to get better pictures of newborn babies' brains. Researchers are using a special type of 'contrast enhanced ultrasound' along with another method called elastography. Contrast enhanced ultrasound uses a very small amount of a safe liquid, or 'contrast agent,' that helps make blood vessels clearer on the scan. Elastography looks at how stiff or soft brain tissue is, which can give clues about its health. The aim is to help doctors better understand and diagnose brain conditions in babies who have suffered oxygen deprivation at birth, had a stroke, developed brain infections, or were born prematurely. The study is looking at babies of all ages and genders to improve care for these vulnerable infants.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Varsinais-Suomen hyvinvointialue

Enrolment target

200

Start

10 Dec 2024

Vastasyntyneiden hypoksis-iskeeminen aivovaurio vastasyntyneiden aivohalvaus vastasyntyneiden keskushermostoinfektiot entiset keskoset lasketussa ajassa

What is this study about?

Imagine doctors want to look really closely at a baby's brain, especially if they're worried about its health. Regular ultrasound scans are helpful, but this study is trying out new, advanced ways to get even more detailed pictures. They are using something called 'contrast enhanced ultrasound.' This is similar to a regular ultrasound, but they also give the baby a very tiny, safe amount of a special liquid. This liquid helps specific parts of the brain, like blood vessels, show up much more clearly on the scan. It's a bit like adding colour to a drawing to make certain lines stand out.

They're also using another technique called 'elastography.' This method helps doctors understand how firm or soft different parts of the brain are. Imagine gently pressing on something to see how bouncy or rigid it is – elastography does something similar but using sound waves. Changes in tissue stiffness can sometimes indicate a problem. By combining these advanced scanning methods, the study hopes to give doctors clearer information about brain damage, strokes, infections, or other issues in newborn babies.

Ultimately, the goal of this study is to improve how doctors understand and care for babies born with or who develop brain problems. This includes babies who might have had problems with oxygen at birth, babies who have had a stroke, those with brain infections, and even babies who were born prematurely and are now at their original due date. By getting better pictures and more information about their brains, doctors can hopefully make better decisions about their treatment and care.

Key takeaways

This study uses new ultrasound techniques to get clearer pictures of newborn brains.
It aims to understand brain problems in babies born early or with birth difficulties.
A safe liquid helps make blood vessels in the brain more visible on scans.
Another technique measures the stiffness of brain tissue for health clues.
The research hopes to improve future diagnosis and care for babies with brain conditions.

Who may be eligible?

Researchers are looking for specific groups of babies to take part in this study. They need babies who were born full-term but spent some time in an intensive care unit during their first day. They are also looking for babies who have experienced problems with oxygen at birth, leading to potential brain injury, or those who have had a stroke.

The study is also interested in babies who were born prematurely (before 37 weeks) once they reach their original due date. Finally, they are including babies with other brain-related conditions that doctors want to understand better. All babies, regardless of their gender, can potentially participate in this research.

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.

Was your baby born full-term but spent time in intensive care on their first day?
Did your baby have problems with oxygen at birth or a newborn stroke?
Was your baby born prematurely and is now near their original due date?
Does your baby have another brain condition that doctors are investigating?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve your baby having these special ultrasound scans. The contrast agent is given as a small injection. The scans are non-invasive, similar to standard ultrasounds. The study does not mention specific numbers of visits or a total duration, but it would involve at least one session for the ultrasound procedures. There aren't any extra medications your baby would need to take as part of this research, beyond the contrast material for the scan itself.

Potential risks and benefits

There might be some potential benefits to your baby from taking part, as the advanced scans could give doctors more detailed information about their brain. However, the main benefit is to future babies, as this research helps us learn more about their conditions. The risks are generally low, as ultrasound is safe, and the contrast dye is widely used and considered safe for babies. As with any medical procedure, there's always a tiny risk, but doctors will discuss these fully with you. You have the right to withdraw your baby from the study at any time without affecting their medical care.

Locations (1)

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

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Unverified
Finland

Common questions

What is 'contrast enhanced ultrasound'?

It's a special type of ultrasound where doctors use a tiny, safe amount of liquid to help specific parts of the brain, like blood vessels, show up more clearly on the scan.

Is the special liquid safe for my baby?

Yes, the liquid (called a contrast agent) used in this study is considered safe and is used in tiny amounts. Your doctors will explain everything in detail.

What is 'elastography'?

Elastography is another type of scan that helps doctors see how firm or soft brain tissue is. This can give important clues about brain health.

Will this study directly help my baby?

While the advanced scans might give your baby's doctors more information, the main goal is to learn more about these conditions to help many babies in the future.

What if I change my mind about my baby participating?

You are free to withdraw your baby from the study at any time, for any reason, and it will not affect their medical care or treatment.