The COMET newborn brain injury trial has recruited its 100th baby, marking a milestone for one of the world’s largest neonatal neuroprotection studies.
The study, funded by the National Institute for Health and Care Research and led by researchers at Imperial College London, is testing whether babies born with mild hypoxic-ischaemic encephalopathy benefit from therapeutic cooling.
Hypoxic-ischaemic encephalopathy, or HIE, is a brain injury caused by reduced oxygen and blood flow around the time of birth.
The 100th participant, Arabella, was recruited at Liverpool Women’s University Hospital on 10 June 2026.
The first child recruited, Farah, joined the trial at Imperial College Healthcare NHS Trust in June 2025 and is now two years old.
Muhammed, her father, 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.”
Sudhin Thayyil, professor of perinatal neuroscience in Imperial’s Department of Brain Sciences and study lead, said: “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.”
Around one in 1,000 babies born in the UK unexpectedly develops mild HIE, often after an otherwise healthy pregnancy.
Thayyil said: “The term ‘mild’ can be misleading, as we now know that around 10 per cent 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 trial aims to find out whether three days of cooling therapy soon after birth can help the brain recover and reduce the risk of later difficulties.
Cooling is usually carried out using a blanket wrapped around the baby. 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 426 newborn babies from 56 hospitals across the UK, Canada, Italy, Austria and Australia.
Dr Reema Garegrat, an NIHR doctoral research fellow at Imperial College London, provides real-time, round-the-clock support to clinicians recruiting babies at participating hospitals.
She said: “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 Garegrat added: “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.”
She said: “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.”
The trial team said it was indebted to the families who agreed to take part.
Dr Stuti Pant, deputy director of the Centre for Perinatal Neuroscience and a postdoctoral researcher leading the trial’s parent and public engagement work, said: “Being approached about research shortly after the birth of a baby with suspected brain injury can be overwhelming.
“Families who take part do so at one of the most emotional and uncertain times in their lives.”
The team said every family taking part was helping to build evidence that would guide neonatal care for years to come.
Dr Balamurugan Palanisami, neonatal consultant at Liverpool Women’s University Hospital, said: “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.”
Arabella’s mother, Kaisha, 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.
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