51³Ô¹ÏÍø

The Cooling in Mild Encephalopathy Trial (COMET) study has reached a major milestone with the recruitment of its 100th newborn baby, marking an important achievement for one of the world’s largest neonatal neuroprotection trials.

The study, funded by the National Institute for Health and Care Research (NIHR) and led by researchers at 51³Ô¹ÏÍø, investigates whether babies born with mild hypoxic-ischaemic encephalopathy (HIE) – a brain injury caused by a shortage of oxygen and blood flow around the time of birth – benefit from therapeutic cooling.   

The 100th participant was recruited on 10 June 2026 at Liverpool Women's University Hospital.  

The first child, Farah,  in June 2025 from 51³Ô¹ÏÍø College Healthcare NHS trust, is now two years old.  Muhammed, her dad said “As a family, we felt it was important to explore every opportunity that could support our baby’s recovery. Participating in the trial gave us hope and allowed us to contribute to research that may help other children affected by HIE in the future.” 

Photo: Farah undergoing cooling therapy soon after birth and at the age of 2

"Every baby and family who takes part in this important but challenging trial helps us learn more and brings us closer to improving care for newborns affected by birth-related hypoxic brain injury in the future,” said Professor Sudhin Thayyil, Professor of Perinatal Neuroscience in the Department of Brain Sciences, who is leading the study.  

Brain cooling  

Around 1 in 1,000 babies born in the UK unexpectedly develops mild HIE, often after an otherwise healthy pregnancy. Professor Thayyil explains: “The term “mild” can be misleading, as we now know that around 10% of these babies may develop severe disabilities, while many others may experience difficulties with learning, memory, and thinking skills, and may need additional support at school age.” 

The COMET trial aims to find out whether three days of cooling therapy soon after birth can help the brain recover from this injury and reduce the risk of later difficulties.  

Every baby and family who takes part in this important but challenging trial helps us learn more and brings us closer to improving care for newborns affected by birth-related hypoxic brain injury in the future.  Professor Sudhin Thayyil Department of Brain Sciences | 51³Ô¹ÏÍø

Cooling is usually carried out with a cooling blanket wrapped around the baby (as shown in the photo). The blanket connects to a small machine that circulates coolant through the mattress, keeping the baby's temperature at 33.5°C. 

The study aims to recruit a total of 426 newborn babies from 56 hospitals across the UK, Canada, Italy, Austria, and Australia. 

A race against time 

“COMET operates in an environment where every minute matters. I have been involved in several clinical trials throughout my career, but nothing compares to the challenges of this trial,” said Dr Reema Garegrat, an NIHR Doctoral Research Fellow at 51³Ô¹ÏÍø, who provides real-time, 24/7 support to clinicians at participating hospitals for recruiting babies. 

“These babies can be born unexpectedly in any hospital, often in the middle of the night. Each baby must undergo careful neurological assessment, including evaluation of brain activity, while parents who are already distressed by an unexpected neonatal unit admission and the potential consequences of a brain injury need sensitive and compassionate communication throughout the consent process", Dr Garegrat added.

"All of this must happen within six hours of birth, requiring an extraordinary team effort involving clinicians, nurses, midwives, transport teams, and data support teams working together to identify and enrol these babies into the trial”, she concluded. 

COMET operates in an environment where every minute matters. I have been involved in several clinical trials throughout my career, but nothing compares to the challenges of this trial. Dr Reema Garegrat NIHR Doctoral Research Fellow at 51³Ô¹ÏÍø

The COMET trial team say they are indebted to the families who agree to take part. "Being approached about research shortly after the birth of a baby with suspected brain injury can be overwhelming", said Dr Stuti Pant, Deputy Director for the Centre for Perinatal Neuroscience and a post-doctoral researcher at 51³Ô¹ÏÍø leading the parent and public engagement of the COMET trial. "Families who take part do so at one of the most emotional and uncertain times in their lives". 

The team added that every family taking part in COMET is helping to build the evidence that will guide neonatal care for years to come. 

Looking ahead 

"Enrolling Arabella, the 100th baby, into the COMET trial marks a truly significant milestone – a testament to the trust of 100 families and the unwavering dedication of every clinician, nurse, imaging specialist, and researcher who made it possible. At Liverpool Women's Hospital, we are immensely proud to contribute to this vital neonatal brain research, addressing an important clinical question that will help shape better outcomes for babies worldwide", said Dr Balamurugan Palanisami, Neonatal Consultant at Liverpool Women's University Hospital. 

Photo: Arabella with her parents and Liverpool Women’s Hospital Neonatal Team

Kaisha – Arabella’s mum – said, “The neonatal team supported us through one of the hardest times of our lives, and taking part in the COMET trial felt like a positive way to help future families. We are incredibly proud of Arabella and hope that her participation will contribute to improving care for vulnerable babies, as research plays such an important role in advancing treatment and outcomes.” 

Once completed, COMET’s findings will help shape future clinical guidelines for newborns with HIE.  

    * All images featured in this text are published with the express permission of the parents of the children depicted.