Groundbreaking research is underway to explore the potential benefits of whole-body hypothermia for neonates suffering from mild hypoxic ischemic encephalopathy (HIE). The COMET trial aims to determine if this treatment can improve cognitive development, a significant concern for affected children as they grow older. The trial’s findings could reshape medical guidelines and healthcare practices worldwide.
Study Design and Recruitment
The COMET trial is a phase III multicentre, open-label, two-arm randomised controlled study, involving 426 neonates recruited from 50 to 60 NHS hospitals over a two-and-a-half-year period. After obtaining parental consent, neonates will be randomly assigned to either a 72-hour whole-body hypothermia treatment (maintained at 33.5 ± 0.5°C) or normothermia (37.0 ± 0.5°C) within six hours of birth. To ensure accurate diagnosis and treatment, clinical staff will be trained and certified in the expanded modified Sarnat staging for encephalopathy.
Monitoring and Assessments
All screened and recruited cases will undergo neurological assessments, which will be video recorded and centrally evaluated for quality assurance. Additionally, neonates will be monitored using continuous amplitude-integrated electroencephalography (aEEG) for at least the first 48 hours to detect seizures. If recruitment occurs at a non-cooling center, neonates will be transferred to a cooling center for further care. Safety outcomes will be documented, and data collected for assessing healthcare resource utilization.
A central team, blinded to the trial group allocations, will assess neurodevelopmental outcomes at two years of age. The primary outcome measure will be the mean difference in composite cognitive scores using the Bayley Scales of Infant and Toddler Development, Fourth Edition.
Economic and Market Access Implications
The results of the COMET trial will have significant implications for market access to whole-body hypothermia treatments. By potentially demonstrating the safety and efficacy of this treatment for mild HIE, the trial could pave the way for wider adoption in high-income countries. This would not only inform national and international guidelines but also provide a comprehensive economic assessment of the therapy’s cost-effectiveness within the NHS framework.
Key Findings
• The COMET trial addresses a critical gap in understanding the benefits of hypothermia for mild HIE, a condition previously untested in this context.
• The trial’s design ensures rigorous quality assurance and accurate monitoring of neurological outcomes, enhancing the reliability of the results.
• Economic assessments will offer valuable insights into the cost-effectiveness of hypothermia therapy, influencing healthcare policies and market access.
The COMET trial is poised to make significant contributions to our understanding of treating mild hypoxic ischemic encephalopathy. By evaluating the safety and efficacy of whole-body hypothermia, this research could lead to improved cognitive outcomes for affected neonates and inform healthcare practices and guidelines globally.
Original Article:
BMC Pediatr. 2024 Jul 18;24(1):460. doi: 10.1186/s12887-024-04935-4.
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