Cooling in Mild Encephalopathy (COMET) trial

Research summary

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.

Principal Investigator

Dr Eleri Adams

Contact us

Email: neonatal.research@ouh.nhs.uk

IRAS number

326176