The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
This study is investigating the long-term effects of a serious brain condition called neonatal encephalopathy (NE) in children who were treated with specific cooling therapy (therapeutic hypothermia) shortly after birth. Researchers want to understand how these children are developing at age 9, focusing on things like learning, attention, social skills, and emotions. They will also look at their brains using special scans. By comparing these children to others who didn't have NE, the study aims to find out what factors might help or hinder their development and improve understanding of this condition.
At a glance
What is this study about?
This important study aims to understand the long-term health and development of children who experienced a serious brain condition at birth, called neonatal encephalopathy (NE), and were treated with a special cooling therapy (therapeutic hypothermia). This cooling treatment became standard about ten years ago and has been very helpful in reducing deaths and severe disabilities. However, doctors are now realizing that some children, even those who seem to recover well, might still face challenges as they grow up, such as difficulties with learning, attention, or social interactions.
At the moment, we don't fully understand the nature and extent of these challenges. This study will look closely at children at age 9 to understand their thinking skills, how they manage their emotions, how they interact with others, and their overall well-being. Researchers will also use special brain scans to see if there are any differences in their brain structure compared to children who didn't have NE.
By carefully comparing these groups, the study hopes to identify specific problems and understand what might cause them. This information is really important because it could help doctors provide better support and care for children who have had NE, ensuring they have the best possible start in life and the support they need as they grow.
Key takeaways
- This study focuses on children aged 8-11 who had a serious brain condition (NE) at birth and received cooling therapy (TH).
- It aims to understand their development, including learning, social skills, and emotions, at age 9.
- Researchers will use special brain scans (MRI) to look at brain structure.
- The study compares these children to others who didn't have NE.
- It involves one study visit with assessments and a brain scan, plus parent questionnaires.
- The goal is to improve future care and support for children affected by NE.
Who may be eligible?
To join this study, children must have been born between 2014 and 2018, meaning they are currently between 8 and 11 years old. They must have received the special cooling treatment (therapeutic hypothermia) for moderate or severe neonatal encephalopathy (NE) within the first six hours of their life, and this treatment continued for 72 hours.
Children cannot take part if they have certain other health conditions, such as infections they were born with, genetic problems, or metabolic disorders (which affect how their body processes food). They also can't participate if they have major differences in their brain structure, or if they have any metal implants in their body or severe claustrophobia, which would prevent them from having a safe MRI scan.
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 child born between 2014 and 2018?
- Did your child receive whole-body cooling (therapeutic hypothermia) for a serious brain condition at birth?
- Was this cooling treatment started within 6 hours of birth and continued for 72 hours?
- Does your child NOT have a history of genetic problems, metabolic disorders, or major brain differences?
- Does your child NOT have any metal implants that would prevent an MRI scan or severe claustrophobia?
What does participation involve?
If your child takes part in this study, you would visit the study centre once. During this visit, your child will complete some standard assessments, which are like fun activities and puzzles, to check their thinking, attention, and social skills. They will also have a safe brain MRI scan, which is similar to a detailed photograph of the inside of their head. While your child is doing this, you, as their parent, will be asked to fill out some questionnaires. You can do this at the study centre or complete them online from home at a time that suits you. The study involves this single visit and the related questionnaire completion.
Potential risks and benefits
Locations (2)
- Centre Hospitalier Universitaire Ste-Justine (CHUSJ).Verified postcodeMontreal, Canada
- the Montreal Children's Hospital (MCH) of the McGill University Health CentreVerified postcodeMontreal, Canada
Common questions
What is neonatal encephalopathy (NE)?
NE is a serious brain condition that can affect babies shortly after they are born, often due to a lack of oxygen or blood flow to the brain.
What is therapeutic hypothermia (TH)?
TH is a treatment where doctors gently cool a newborn baby's body to help protect their brain after a brain injury or NE.
Will my child get any special treatment in this study?
No, this study is about understanding how children are doing; it doesn't involve new medication or treatments for your child. It helps us learn for future care.
Is the brain scan safe for my child?
Yes, MRI scans are very safe. They use strong magnets and radio waves, not radiation like X-rays, to create detailed pictures of the brain.
How long will the study visit take?
The study visit will take a few hours, as it involves several assessments and the MRI scan for your child, and time for you to complete questionnaires.
How to find out more
Marie Brossard-Racine, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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