Not yet recruitingPHASE2INTERVENTIONAL

The PROTECT-HIE Pilot Trial

The PROTECT-HIE trial is investigating ways to help babies with a brain injury at birth called HIE (Hypoxic-Ischemic Encephalopathy). These babies receive cooling treatment to protect their brains. Often, they also develop heart problems or poor blood flow, which can make things worse. Doctors often use medicines like dobutamine to help the heart, but usually only after problems show up. This study wants to see if giving a small dose of dobutamine earlier, before heart problems become severe, is safe and possible. The idea is that early heart support might improve blood flow to vital organs, including the brain, and lead to better health outcomes for these vulnerable newborns.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University of Alberta

Enrolment target

Start

15 Jul 2026

Estimated completion

30 Apr 2029

Hypoxic-ischemic Encephalopathy (HIE)

What is this study about?

When some babies are born, they might not get enough oxygen and blood flow. This can lead to a serious condition called HIE, which can affect their brain and other organs, including the heart. To help protect the brain, these babies are usually given a special treatment called therapeutic hypothermia, where their body temperature is gently lowered for a few days.

Even with cooling treatment, many babies with HIE can still have heart problems or poor blood circulation. Doctors often use medicines to help the heart, but it's not clear which medicine works best or when it should be given. One common medicine is called dobutamine, which helps the heart pump more strongly. Usually, this medicine is given only after a baby starts showing clear signs that their heart isn't working well.

This study, called PROTECT-HIE, wants to find out if it's safe and helpful to give a low dose of dobutamine much earlier to babies with HIE who are also having cooling treatment. The researchers believe that supporting the heart early on might improve blood flow to the brain and other important organs, potentially reducing harm and leading to better recovery. They will compare babies who get this early medicine with others who get a dummy treatment to see if it makes a difference.

Key takeaways

The study aims to improve care for babies with HIE.
It tests if early heart support with dobutamine is safe and helpful.
Babies will be randomly assigned to receive dobutamine or an inactive fluid.
Researchers will check for safety, brain health, and heart function.
The study is a 'pilot' to see if a larger study should be done.
Parents will be asked for consent after their baby is stabilised due to the urgent nature of HIE.

Who may be eligible?

This study is for newborn babies who have a condition called Hypoxic-Ischemic Encephalopathy (HIE) and are receiving the special cooling treatment to protect their brains. It's for babies who are roughly one day old.

Babies would not be able to join the study if they have certain conditions. For example, if they have another birth defect or if they have a known reason why they shouldn't receive dobutamine, such as a severe heart problem or an allergy to the medication.

Also, babies who are already receiving other strong heart-supporting medications at the time the study would begin would not be eligible. Finally, if parents decide they don't want their baby to take part, that is also a reason not to join.

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 a newborn (around 1 day old)?
Does my baby have Hypoxic-Ischemic Encephalopathy (HIE)?
Is my baby receiving cooling treatment?
Does my baby have any other birth defects or a known allergy to dobutamine?
Is my baby already on strong heart-supporting medications?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they will be placed into one of two groups by chance, like flipping a coin. One group will receive a low dose of the medicine dobutamine, and the other group will receive an inactive fluid (a placebo). Neither you nor the medical team looking after your baby will know which treatment they are receiving, so everyone is treated the same. This special medicine or placebo will be given within the first four hours of your baby starting their cooling treatment. The main part of the study focuses on this early treatment period while your baby is in the neonatal intensive care unit (NICU). Researchers will closely monitor your baby's health, including their brain scans (MRI), heart function (using ultrasound), and other important measurements like blood tests. They will also track how long your baby stays in hospital and their overall survival.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could improve care for future babies with HIE. There's a chance, though not guaranteed, that your baby might benefit from the early heart support if they receive the dobutamine. The dobutamine medicine is already used in babies, but the study is testing it earlier than usual. Potential risks could include side effects from the dobutamine, though the study is designed to be as safe as possible and to closely monitor for any issues. The treatment involves a medicine that is commonly used in intensive care, but there is always a chance of unexpected effects. You are free to withdraw your baby from the study at any time, for any reason, and this will not affect the quality of care they receive.

Locations (1)

Royal Alexandra Hospital
Verified postcode
Edmonton, Canada

Common questions

What is HIE?

HIE stands for Hypoxic-Ischemic Encephalopathy. It's a brain injury in newborns caused by a lack of oxygen and blood flow around birth.

What is cooling treatment?

Cooling treatment, or therapeutic hypothermia, is when a baby's body temperature is gently lowered for several days to help protect their brain after an HIE injury.

What is dobutamine?

Dobutamine is a medicine that helps the heart pump more effectively. It's already used in newborn intensive care units when babies have heart weakness.

Why join a study when my baby is so unwell?

Because HIE is an emergency, and treatment needs to start very quickly after birth, parents are asked to give consent for the study after their baby is stable. This approach is common in emergency newborn research.

How will I know if my baby got the real medicine or the placebo?

Neither you nor the medical team caring for your baby will know whether they received dobutamine or the placebo during the study. This helps ensure the study results are unbiased.

How to find out more

Aimann Surak, MD FRCPC

aimann@ualberta.ca 780-735-4647 Official trial record

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