Effect of ALlopurinol in addition to hypothermia for hypoxicischemic Brain Injury on Neurocognitive Outcome
This clinical trial is studying babies who have experienced a particular type of brain injury during or just after birth, called hypoxic-ischemic encephalopathy (HIE). This injury can happen due to various problems during labour like placental issues or cord complications. The study aims to see if adding a medicine called allopurinol to the standard cooling treatment these babies receive can improve their long-term development. Specifically, it's looking at whether allopurinol can reduce the risk of death or severe developmental problems by the time the children are two years old. This is a Phase III study, which means it's a larger trial to confirm if the new treatment is safe and effective.
At a glance
What is this study about?
This study is about a very serious condition that can affect babies during birth. Sometimes, a baby might not get enough oxygen or blood flow to their brain, which can cause a brain injury. Doctors call this 'hypoxic-ischemic encephalopathy' or HIE. It can happen for several reasons, such as problems with the placenta, issues with the umbilical cord, or other complications during labour and delivery. HIE can have lasting effects on a child's development.
Currently, babies with HIE are often treated with a special cooling therapy. This treatment helps to protect the brain, but researchers are always looking for ways to improve outcomes. This trial is investigating whether adding a medicine called allopurinol to the cooling treatment could give these babies an even better chance. Allopurinol is already used for other medical conditions, and this study aims to see if it can also help protect the brain from further damage after HIE.
The main goal of the study is to see how babies are doing when they reach two years old. Researchers will compare babies who receive allopurinol with those who don't, looking at whether they survive without serious developmental problems. They'll also check for specific developmental milestones, such as how well the children move, think, and communicate, to understand the full impact of the treatment.
Key takeaways
- This study is for babies who have suffered a specific birth-related brain injury (HIE).
- It's testing if an existing medicine, allopurinol, can improve outcomes when added to cooling treatment.
- The main goal is to see how children develop by age two.
- Babies will be closely monitored, and families can withdraw at any time.
- This is a Phase III study, which means it’s a larger trial to confirm if the treatment works.
Who may be eligible?
This study is open to babies of any age and sex who have experienced the specific type of brain injury called hypoxic-ischemic encephalopathy (HIE).
The doctors involved in the study will carefully assess each baby to make sure they meet all the specific criteria. This ensures that the study is conducted safely and that the results will be meaningful for future treatment of HIE. Only babies with this particular condition will be able to take part.
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.
- Has my baby been diagnosed with hypoxic-ischemic encephalopathy (HIE)?
- Is my baby currently receiving or eligible for standard cooling treatment?
- Am I comfortable with my baby potentially receiving either the study medicine or an inactive placebo?
- Am I able to commit to follow-up assessments until my child is two years old?
What does participation involve?
If your baby is eligible and you agree for them to take part, they will receive either the study medicine (allopurinol) or a placebo (an inactive substance that looks just like the study medicine) in addition to their standard cooling treatment. The medicine will be given as a liquid through a drip.
Throughout the study, your baby will have regular medical check-ups and assessments. The main follow-up for the study will be when your child reaches two years of age. At this point, specialists will conduct a thorough assessment of their development, looking at things like their movement, thinking, and language abilities. This will help the researchers understand the long-term effects of the treatment. The total duration of active participation and follow-up will be until your child is two years old.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedFinland
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedEstonia
- —UnverifiedBelgium
Common questions
What is HIE?
HIE stands for hypoxic-ischemic encephalopathy. It's a type of brain injury that can happen to babies during or shortly after birth if their brain doesn't get enough oxygen or blood flow.
What is allopurinol?
Allopurinol is a medicine that's being tested to see if it can help protect the brain after an HIE injury, in addition to the usual cooling treatment.
Will my baby still get the usual cooling treatment?
Yes, all babies in this study will receive the standard cooling treatment, which is currently used for HIE. The study medicine is given in addition to this.
What kind of developmental assessments will my child have?
When your child is two years old, they will have assessments to check their physical movement, how they learn and understand things, and how they use language. This helps understand their overall development.
Can I change my mind about my baby being in the study?
Absolutely. You can withdraw your baby from the study at any time, and it won't affect the medical care they receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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