Not yet recruitingOBSERVATIONAL

Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates

This study aims to discover if a new device, a 'pupillometer', can help doctors understand how well a newborn baby's brain is recovering after a difficult birth where they didn't get enough oxygen or blood (called Hypoxic Ischemic Encephalopathy, or HIE). When a baby has HIE, doctors need to check their brain function often. Currently, they use a regular penlight to check eye response, but this isn't very accurate. The pupillometer is a gentle, handheld device that accurately measures how a baby's eye reacts to light. The study wants to see if the measurements from this device can show how healthy the baby's brain is and if it can predict potential problems. Taking part won't change your baby's treatment; it's simply an extra check during their usual care.

At a glance

Status

Not yet recruiting

Sponsor

University of Calgary

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Jun 2026

Hypoxic Ischemic Encephalopathy (HIE)

What is this study about?

When a baby is born and doesn't get enough oxygen or blood to their brain, it's called Hypoxic Ischemic Encephalopathy, or HIE. This can sometimes affect how their brain develops. Doctors need to check the baby's brain function very carefully and often to make sure they are recovering well. One way they do this is by looking at how a baby's pupils (the black center of the eye) react to light. Currently, doctors often use a simple penlight, but this can be a bit tricky because different people might interpret the reaction differently, making it hard to get a consistent measurement.

This study is looking at a new, gentle device called a 'pupillometer'. It's a handheld device that doesn't touch the eye. It can give a clear, accurate measurement of how the pupil reacts to light and also provides a special number called the 'Neurological Pupil Index' (NPi). This NPi number has been used in adults and older children to help doctors understand brain health, but we don't know yet what it means for newborn babies.

The main goal of this study is to see if this NPi number can tell us more about a newborn baby's brain health after HIE. The researchers want to find out if a lower NPi number means there might be more changes in the baby's brain activity (measured by another test called an EEG) or if it increases the chance of other problems like seizures, feeding difficulties, or changes seen on a brain scan. This study will not change how your baby is cared for; it's just about using a new tool to get more information during their routine checks.

Key takeaways

The study investigates a new device called a 'pupillometer' for newborn brain health.
It aims to see if eye reaction to light can show how a baby's brain is recovering after HIE.
Participation involves extra, gentle eye checks during routine care.
Your baby's medical treatment will not be altered by joining the study.
The pupillometer is a safe, non-contact device.
Results could help doctors better understand and monitor babies with HIE in the future.

Who may be eligible?

This study is looking for newborn babies who meet certain criteria. Your baby might be able to take part if they were born at or after 35 weeks of pregnancy and have been diagnosed with Hypoxic Ischemic Encephalopathy (HIE). They also need to be cared for in the special baby unit at Alberta Children's Hospital in Calgary.

There are some reasons why a baby might not be able to join the study. These include if they have certain genetic conditions or birth defects, or if they have an injury or problem with their eyes that would make it difficult to use the pupillometer. Also, if there isn't enough information from other routine tests, the baby might not be included.

The study is interested in newborns from birth up to 6 hours old at the time of their first assessment. If your baby fits these descriptions, their doctors might talk to you about joining.

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 35 weeks old at birth?
Has my baby been diagnosed with Hypoxic Ischemic Encephalopathy (HIE)?
Is my baby currently being cared for in the neonatal neuro-intensive care unit at Alberta Children's Hospital?
Does my baby have any existing eye injuries or conditions that would prevent a clear eye measurement?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, you'll first be asked to give your permission (this is called 'informed consent'). Your baby will then have their neurological examination and eye checks using the pupillometer at five different times: when they are first admitted, then at 24 hours, 48 hours, and 72 hours old, and finally just before they go home. During these checks, the pupillometer will be gently used on both of your baby's eyes. It’s a non-contact device, meaning it doesn't touch your baby. The device only takes a short measurement. This extra check will happen during your baby's usual care and will not change any of their medical treatments or how they are looked after. Other routine information, like brain activity readings (EEG) and brain scans (MRI) that are already part of their care, will also be used in the study.

Potential risks and benefits

Taking part in this study offers the potential benefit of helping doctors learn more about how to best understand and monitor brain recovery in newborn babies with HIE. This research could lead to better ways of caring for babies in the future. The pupillometer device itself is very safe; it doesn't touch your baby's eyes and has already been approved for use in all age groups. It poses no new risks beyond the usual care. Your baby's treatment will not change because of their participation. You have the right to withdraw your baby from the study at any time without it affecting their medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is HIE?

HIE stands for Hypoxic Ischemic Encephalopathy. It's a condition where a newborn baby's brain doesn't get enough oxygen or blood flow, often around the time of birth.

What is a 'pupillometer'?

It's a small, handheld device that gently measures how a baby's eyes react to light. It doesn't touch the baby's eye and gives an accurate reading.

Will my baby's treatment change if we join?

No, your baby's medical care and treatment will stay exactly the same. The pupillometer simply provides extra information during their routine checks.

Is the pupillometer safe for my baby?

Yes, it's very safe. It's a non-contact device, meaning it doesn't touch your baby's eyes, and it has already been approved for safe use.

How many times will the pupillometer be used?

The pupillometer will be used five times during your baby's hospital stay: at admission, 24, 48, and 72 hours, and once before discharge.

How to find out more

Khorshid Mohammad, MD, Mac, FRCP, FRCPC

khorshid.mohammad@albertahealthservices.ca 587-893-0700 Official trial record

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