Invitation to join

Latest COMET recruit from Derriford Hospital, Plymouth. Dr Melanie Phillips (PI) and Heidi Holland (research nurse)

Multi-centre, randomised, open-label clinical trial

• Aim: Evaluate the safety, efficacy and cost-effectiveness of whole-body hypothermia as a therapy for babies with mild HIE.
• Recruitment: We aim to recruit 426 babies born ≥ 36 weeks gestation with mild HIE from 60-100 hospitals in the UK, Europe, Canada and Australia.
• Inclusion Criteria: 1) Cord pH <7 or BE ≥ 16 or Apgar<5 or continued resuscitation @10 min 2) Mild encephalopathy on expanded modified Sarnat stage by certified examiners 3) Normal aEEG voltage and no seizures.
• Exclusion Criteria: 1) Babies meeting NICHD NRN or TOBY trial (BAPM) cooling criteria 2) Babies who received anti-convulsants before randomization or those initiated on cooling therapy.
• Sites: We are inviting all NICUs, SCBU and LNUs with aEEG monitoring facilities to join the COMET trial as recruiting sites.
• Training: As part of the trial we are also providing certification for ‘extended modified Sarnat staging of neonatal encephalopathy’ with the wider aim to standardise HIE staging and reduce the identified effects of therapeutic drift.

To find out more visit: https://www.imperial.ac.uk/perinatal-neuroscience/comet-trial/

To register your interest in the trial email: COMET@imperial.ac.uk