Active not recruitingOBSERVATIONAL

Investigating Cerebral Oxygenation in the Newborn

This study uses a safe and gentle light-based monitor to check oxygen levels in the brains of newborn babies. We're looking at two groups of babies: those with brain injury from lack of oxygen around birth, and babies born very prematurely. The aim is to see if measuring brain oxygen can show us how well their brains are doing. For babies with brain injury, we want to know if oxygen levels during treatment reflect what we see on brain scans later. For premature babies, we're checking if oxygen levels are different during skin-to-skin care or if they have certain lung problems. This research could help us find better ways to check on these vulnerable babies.

At a glance

Status

Active not recruiting

Sponsor

University of Edinburgh

Enrolment target

Start

21 Jul 2023

Estimated completion

01 May 2027

Hypoxic Ischemic Encephalopathy of Newborn Neonatal Encephalopathy Premature Infant Disease

What is this study about?

This research study is about understanding how oxygen levels in a newborn baby's brain can give us clues about their brain health. We're using a special, safe device called a Near-infrared spectroscopy (NIRS) monitor, which shines a gentle light on the baby's head to measure how much oxygen is in the brain tissue. This monitor is already used in hospitals and is completely painless for the baby.

The study focuses on two groups of babies who are at higher risk of brain problems. The first group includes babies born at or close to full-term who have had a brain injury due to lack of oxygen around the time of birth. These babies often receive a special cooling treatment. We want to see if the brain oxygen readings from the NIRS monitor during and after this cooling treatment tell us anything about what doctors find later on detailed brain scans. The second group is made up of babies born very prematurely, before 28 weeks of pregnancy. For these tiny babies, we want to see if their brain oxygen levels change during comforting skin-to-skin care, and whether their oxygen levels are different if they have certain lung conditions.

The main idea is to find out if this simple, safe monitoring method can help doctors understand and potentially identify brain injury earlier. This could lead to better ways to care for these babies in the future and guide new treatments if needed. Your baby's care will not change because of participating in this study; this is about gathering more information to help future babies.

Key takeaways

The study uses a safe, gentle monitor to check brain oxygen in sick newborns.
It aims to understand if oxygen levels can help predict brain health.
It includes babies with brain injury and very premature babies.
No new treatments or risks are part of this study.
Participation will not change your baby's medical care.
You can withdraw your baby from the study at any point.

Who may be eligible?

This study is looking for two types of newborn babies. The first group includes babies born at 34 weeks or more who are receiving a special cooling treatment for a serious brain injury caused by a lack of oxygen around birth. They must show certain signs like a low Apgar score, needing help to breathe, or specific blood test results, along with signs of moderate to severe brain problems, like being very sleepy or having weak reflexes.

The second group is for babies born very prematurely, before 28 weeks of pregnancy. For a part of this study, they need to be well enough for skin-to-skin contact with their parents. Another part of this group is for babies born before 28 weeks who survive until 36 weeks after conception, allowing us to compare babies with and without a specific lung condition.

We cannot include babies with serious birth defects that could be life-threatening or whose brain problems are due to something other than lack of oxygen. Also, babies whose parents decide not to participate cannot be included.

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 my baby at least 34 weeks gestation and receiving cooling treatment for brain injury?
Or, was my baby born before 28 weeks gestation?
Have I given permission for my baby to take part in research?
Does my baby NOT have a life-threatening birth defect?
Is my baby already receiving active medical care in the hospital?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will have a small, soft sensor placed on their head, similar to a bandage, which uses a gentle light to measure brain oxygen levels. This is a non-invasive process and won't cause any discomfort to your baby. The monitoring will happen while your baby is already receiving care in the Neonatal Intensive Care Unit (NICU). The exact duration and timing of the monitoring will depend on which group your baby is in. For example, some babies might be monitored during their cooling treatment or during skin-to-skin care. There are no extra hospital visits or medications involved specifically for this study. The total duration of participation depends on whether your baby is in the full-term or preterm group and the specific aims they are contributing to, but it will only involve monitoring while they are already being cared for in the NICU.

Potential risks and benefits

There are no known direct medical benefits for your baby from participating in this study, but the information we gather could help improve care for future babies with similar conditions. Because the NIRS monitor is already a standard, safe device used in baby care, there are no additional risks to your baby's health from participating. The sensors are gentle, non-invasive, and will not cause any pain. You are always free to change your mind and withdraw your baby from the study at any time, for any reason, without it affecting your baby's medical care.

Locations (1)

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

Royal Infirmary of Edinburgh
Verified postcode
Edinburgh, United Kingdom

Common questions

What is the NIRS monitor?

It's a small device that uses a gentle, safe light on your baby's head to measure how much oxygen is in their brain. It's painless and non-invasive.

Will my baby get any extra treatments because of this study?

No, your baby's medical care and any treatments they need will remain exactly the same. This study is purely for gathering information.

Is the light from the monitor harmful?

No, the light used by the NIRS monitor is very dim and completely safe. It's a routine monitoring method used in many hospitals.

What happens to the information collected from my baby?

The information will be used for research to help us understand brain health in babies better. All data will be kept private and your baby's identity will be protected.

Can I decide to take my baby out of the study later?

Yes, absolutely. You can withdraw your baby from the study at any time, for any reason, and it will not affect the care they receive.