RecruitingPHASE3INTERVENTIONAL

Cooling in Mild Encephalopathy

This study, called COMET, is testing if lowering a baby's body temperature for 72 hours can help babies who have a mild brain injury at birth. Doctors will carefully cool some babies to around 33.5°C, while others receive standard care to maintain a normal body temperature of about 37°C. The main goal is to see if cooling improves how babies develop their thinking and movement skills by two years of age. Researchers also want to find out if this treatment is a good use of NHS resources. This information will help create better care guidelines for babies across the UK.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Imperial College London

Enrolment target

426

Start

15 Mar 2024

Estimated completion

01 Jan 2030

Neonatal Encephalopathy Newborn Asphyxia

What is this study about?

When a baby has a difficult birth, sometimes their brain doesn't get enough oxygen, which can lead to a condition called neonatal encephalopathy. This study focuses on babies with a *mild* form of this injury.

For babies with more serious brain injuries, cooling them down slightly (called hypothermia) has already been shown to help. But we don't know the full effect for babies with milder injuries. This study aims to find out if gentle cooling for 72 hours, starting soon after birth, can help these babies develop better, particularly in their thinking and movement skills, by the time they are two years old. The researchers will compare babies who are cooled with those who receive standard care to keep their body temperature normal.

The findings from this research are really important. They will help doctors and nurses across the NHS decide the best way to care for babies with mild brain injury. This means making sure all babies get the most effective and appropriate treatment, and that the care provided is also good value for money for the health service. Ultimately, the goal is to improve the health and well-being of these vulnerable newborns.

Key takeaways

This study evaluates gentle cooling for newborns with mild brain injury.
It compares cooling to standard temperature care over 72 hours.
The main goal is to improve children's development by age two.
Findings will help NHS doctors create better guidelines for baby care.
It also assesses if cooling is a cost-effective treatment for the NHS.

Who may be eligible?

This study is for very specific cases. Babies can be considered if they were born at 36 weeks or later, weigh at least 1800g, and had a difficult birth, such as needing a lot of help with breathing or having a specific level of acidity in their blood.

They must also show signs of *mild* brain injury (neonatal encephalopathy). This is carefully checked by doctors through a special examination and a brain activity scan (aEEG) within 1 to 6 hours after birth. If a baby has a more serious brain injury, or no injury at all, they wouldn't be right for this particular study.

Babies would also not be eligible if they have certain major health problems like birth defects or genetic conditions, or if they have already been given certain medications before the brain injury assessment.

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 at 36 weeks or later?
Did your baby weigh at least 1800g (about 4 pounds)?
Did your baby need a lot of help breathing at birth, or have specific blood acidity levels?
Did doctors diagnose *mild* brain injury in your baby using a specific exam and brain monitor within 6 hours of birth?
Does your baby *not* have major birth defects or serious genetic conditions?

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 randomly assigned to one of two groups, like flipping a coin. One group will receive gentle cooling (whole-body hypothermia) for 72 hours, while the other group will receive standard care to maintain a normal body temperature. This will start within 6 hours of birth.

During this time, babies in both groups will receive intensive care support. If they were born at a hospital without specialist cooling facilities, they would be moved to the nearest cooling centre (a Neonatal Intensive Care Unit or NICU) for their care. Crucially, at 24 months of age (two years old), your child will have a special assessment called the Bayley Scales of Infant and Toddler Development-IV. This is a play-based assessment that looks at their cognitive (thinking) and motor (movement) skills. Researchers will then compare the results between the two groups.

Potential risks and benefits

Participating in this study might offer a potential benefit if cooling proves more effective in helping a baby's brain development. However, there may also be unknown risks associated with the cooling treatment for mild brain injury, as this is precisely what the study aims to uncover. All babies in the study will receive excellent medical care, whether they are cooled or receive standard temperature management. You are free to withdraw your baby from the study at any time without affecting their medical care.

Locations (39)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"
Verified postcode
Naples, Italy· Recruiting
William Harvey Hospital
Verified postcode
Ashford, United Kingdom· Recruiting
St Peters Hosptial
Verified postcode
Ashford, United Kingdom· Recruiting
Birmingham Heartlands
Verified postcode
Birmingham, United Kingdom· Recruiting
Royal Bolton Hosptial
Verified postcode
Bolton, United Kingdom· Recruiting
Bradford Royal Infirmary
Verified postcode
Bradford, United Kingdom· Recruiting
Royal Sussex County Hospital
Verified postcode
Brighton, United Kingdom· Recruiting
St Michael's Hospital
Verified postcode
Bristol, United Kingdom· Recruiting
Southmead Hosptial
Verified postcode
Bristol, United Kingdom· Recruiting
Rosie Maternity Hosptial, Addenbrookes
Verified postcode
Cambridge, United Kingdom· Recruiting
University Hospital Coventry
Verified postcode
Coventry, United Kingdom· Recruiting
Darent Valley Hospital
Verified postcode
Dartford, United Kingdom· Recruiting

Common questions

What is 'mild brain injury' in newborns?

It's when a baby's brain doesn't get enough oxygen during birth, leading to some, but not severe, changes in their brain function, checked by doctors.

What does 'cooling' mean?

It means gently lowering a baby's body temperature to around 33.5 degrees Celsius for 72 hours, using a special cooling blanket or mattress.

Will my baby get the best care if they're in the study?

Yes, all babies in the study, regardless of which group they're in, will receive high-quality neonatal intensive care from experienced medical teams.

How will you know if cooling works?

Researchers will assess your child's development, especially their thinking and movement skills, at two years of age to see how both groups compare.

Can I change my mind about my baby being in the study?

Absolutely, you can withdraw your baby from the study at any point, and it will not affect the medical care they receive.

How to find out more

Sudhin Thayyil, MD, PhD

s.thayyil@imperial.ac.uk 02033132473 Official trial record

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