RecruitingOBSERVATIONAL

Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

This study, called EMBLEM, is looking into why some babies born very early (before 29 weeks) develop long-term lung problems like bronchopulmonary dysplasia (BPD). BPD can affect a child’s health and development for many years. We're using new types of MRI scans to get a clear picture of their tiny lung tissues and blood vessels. These scans, along with heart scans (echocardiograms) and lung function tests, will help us identify early warning signs of serious lung disease. If we can predict which babies are most at risk, doctors can offer earlier support and develop better treatments to improve their health in the long run. The study will follow 319 babies, tracking their lung health and development up to 21 months of age.

At a glance

Status

Recruiting

Sponsor

Children's Hospital of Eastern Ontario

Enrolment target

319

Start

30 Mar 2024

Estimated completion

30 Jun 2027

Lung Function BPD - Bronchopulmonary Dysplasia

What is this study about?

When babies are born very early, their lungs might not be fully developed, leading to a condition called bronchopulmonary dysplasia, or BPD. This can cause breathing difficulties and other health problems that can last into adulthood. Currently, it's quite hard for doctors to tell early on which premature babies will develop severe BPD and which ones will have milder forms. This study aims to change that.

We believe that both the lung tissue itself and the tiny blood vessels within the lungs play a big part in BPD. This study is using advanced MRI scans, which are special detailed pictures, to look closely at these parts of the lungs. By doing this, we hope to find early 'clues' or 'biomarkers' in these tiny babies that can predict who will go on to have more significant lung problems. We'll also use other tests like heart scans (echocardiograms) and lung ultrasound to get a full picture of their health.

The real benefit here is that if we can identify babies at high risk much earlier, we can offer more focused care and support to them and their families. This could mean trying new treatments sooner or making sure they get all the help they need. Ultimately, this research could lead to better ways to prevent and treat long-term lung disease in premature babies, giving them the best possible start in life.

Key takeaways

Aims to predict long-term lung problems in premature babies.
Uses advanced MRI scans, heart scans, and lung function tests.
Involves babies born before 29 weeks of pregnancy.
Follows babies from birth up to 21 months of age.
Could lead to earlier support and better treatments for premature babies.
Participation includes scans, tests, and phone calls. No new medications.

Who may be eligible?

This study is looking for very premature babies to take part. To be eligible, babies must have been born before 29 weeks of pregnancy (which is about 7 months). When they join the study, they also need to be less than 36 weeks 'post-menstrual age' – this means less than 36 weeks from the first day of their mother's last period, regardless of when they were actually born.

There are also some reasons why a baby might not be able to join. For example, if a baby has certain known lung conditions, heart problems (other than very common and often harmless ones), or other serious health issues or genetic conditions, they wouldn't be able to participate. Also, if a baby can't safely have an MRI scan or needs constant breathing support that can't be briefly paused for the scan, they wouldn't be able to join. Your family also needs to be able to speak English.

Finally, for a baby to be part of the study, they need to be receiving their follow-up care at one of the four hospitals involved in this research. If they've been transferred to a different hospital before their first study visit, they wouldn't be eligible.

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 baby born before 29 weeks of pregnancy?
Is your baby currently less than 36 weeks old (counting from the start of your last period)?
Does your baby NOT have any serious known lung problems, heart problems (other than common minor ones), or major genetic conditions?
Can your baby safely have an MRI scan?
Can you speak English?
Does your baby receive their hospital follow-up care at one of the study's participating hospitals?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will have several check-ups. At around 36 weeks 'post-conception' (which means 36 weeks from when they were conceived), they will have a special lung MRI scan, a lung function test called oscillometry, and an echocardiogram (a scan of their heart). These tests help the doctors understand your baby's lung and heart health. There are no medications given as part of this study.

After these initial tests, the research team will keep in touch with you every three months. This will involve phone calls to ask about your baby's breathing and general health, and reviewing their medical notes. Then, when your baby is between 18 and 21 months 'post-conception', they will have two more important assessments: a check-up to see how their development is progressing and another lung function test. These follow-up assessments help the researchers see how their lung health and development are progressing over time.

Potential risks and benefits

Taking part in research always has potential benefits and risks. For your baby, the main benefit is that we are trying to learn more about how to predict and treat lung problems in premature babies. While your baby might not directly benefit from new treatments during the study, the information we gather could help many other babies in the future. The risks involved are generally small and linked to the tests, such as the MRI scan, which is a safe procedure but requires careful monitoring of your baby. You will be given a full explanation of all possible risks before making a decision. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (4)

The Children's Hospital of Eastern Ontario
Verified postcode
Ottawa, Canada· Recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting
CHU-Sainte Justine
Verified postcode
Montreal, Canada· Active not recruiting
Montreal Children's Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is Bronchopulmonary Dysplasia (BPD)?

BPD is a long-term lung condition that can affect babies born very prematurely. It means their lungs might not be fully developed or might have been injured, leading to breathing difficulties.

What is an MRI scan and is it safe for my baby?

An MRI uses powerful magnets and radio waves to create detailed pictures inside the body. It doesn't use X-rays. For babies, special care is taken to ensure they are safe and comfortable during the scan, with their breathing and heart rate closely monitored.

Will my baby receive any new medicines in this study?

No, this is an 'observational' study. This means we are only looking at your baby's health through scans and tests. Your baby will not receive any new or experimental medications as part of this research.

How often will I need to visit the hospital?

After the initial set of scans and tests around 36 weeks post-conception, you'll mainly have phone calls every three months. There will be one more visit for assessments when your baby is 18-21 months post-conception.

What if my baby isn't feeling well on a study visit day?

Your baby's health and comfort are the top priority. If your baby is unwell, the study visit can be rescheduled. Please always discuss any concerns with the study team or your doctor.

How to find out more

Sherri Katz

skatz@cheo.on.ca (613) 737-7600 Official trial record

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