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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Thilipan
Thaventhiran
thilipan.thaventhiran@kcl.ac.uk
Dr
Sudhin
Thayyil
s.thayyil@imperial.ac.uk
Reema
Garegrat
r.garegrat@imperial.ac.uk
Thilipan
Thaventhiran
tt206@ic.ac.uk
Dr
Sudhin
Thayyil
s.thayyil@imperial.ac.uk
Dr
Hatty
Bird
hatty.bird@nihr.ac.uk
Study
Team
comet@imperial.ac.uk
Jana
Vaskova
jana.vaskova@nihr.ac.uk
Other disorders originating in the perinatal period
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Despite the lack of evidence on safety or efficacy, many clinicians offer whole body therapeutic hypothermia to infants with mild hypoxic ischaemic encephalopathy, and even to those without any encephalopathy. Such a wide variation in clinical practice within the NHS not only leads to poorer outcomes and may harm infants who would have otherwise done well, but masks improvements in obstetric care and increase litigations.
The COMET trial will establish the safety and efficacy of whole-body hypothermia for mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and will establish uniform practice across the NHS.
Primary objective
To examine if whole-body hypothermia to 33.5 +0.5°C initiated within 6h of birth and continued for 72h, improves cognitive development at two years of age after mild hypoxic ischaemic encephalopathy compared with targeted normothermia at 36.5 +0.5 °C.
Secondary objectives
1. To compare the adverse events in the whole-body hypothermia and targeted normothermia groups.
2. To estimate the cost-effectiveness and economic value of whole-body hypothermia for mild encephalopathy from an NHS and personal social services (PSS) perspective.
COMET is a phase III prospective multi-centre open label two-arm randomised controlled trial with internal pilot and masked outcome assessments. All babies born at or after 36 weeks and requiring prolonged resuscitation at birth (defined as continued resuscitation at 10 minutes after birth or 10-minute Apgar score less than 6) or those with severe birth acidosis admitted to the neonatal unit will be screened. 426 eligible babies will be recruited from six operational delivery networks (ODN) involving a total of 60 NHS hospitals.
The primary outcome is the mean cognitive composite score from the at 24 months. Secondary outcomes will include survival without any neurodisability and microcephaly. Short term outcomes include short term neonatal morbidity and brain injury scores on MR imaging.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Device;Management of Care;Active Monitoring;
You can take part if:
You may not be able to take part if:
1) Infants who meet the BAPM criteria for whole-body hypothermia 2) Infants without encephalopathy defined as less than two abnormalities on structured neurological examination. 3) Infants with major congenital or chromosomal anomalies identified prior to randomisation. 4) Infants with birthweight < 1800g. 5) Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment. 6) Infants already enrolled in interventional studies.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Jana
Vaskova
jana.vaskova@nihr.ac.uk
Study
Team
comet@imperial.ac.uk
Thilipan
Thaventhiran
tt206@ic.ac.uk
Dr
Sudhin
Thayyil
s.thayyil@imperial.ac.uk
Dr
Sudhin
Thayyil
s.thayyil@imperial.ac.uk
Dr
Hatty
Bird
hatty.bird@nihr.ac.uk
Thilipan
Thaventhiran
thilipan.thaventhiran@kcl.ac.uk
Reema
Garegrat
r.garegrat@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 58789
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