NCT05889507: COMET

Cooling in Mild Encephalopathy

Recruiting now Phase 3 Last updated 6 February 2026

What this trial tests

Phase 3 trial testing Whole body hypothermia in Neonatal Encephalopathy in 426 participants. Currently enrolling.

Timeline

15 March 2024

Primary endpoint
1 January 2030

1 January 2030

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	426
Start date	15 March 2024
Primary completion	1 January 2030
Estimated completion	1 January 2030
Sites	39 locations across Italy, United Kingdom

Drugs / interventions tested

• Whole body hypothermia
• Targeted normothermia
• Supportive neonatal intensive care
• Follow up assessment at 2 years of age

Conditions studied

• Neonatal Encephalopathy — all drugs for Neonatal Encephalopathy →
• Newborn Asphyxia — all drugs for Newborn Asphyxia →

Sponsor

Imperial College London

Who can join

Adults 1 Hour to 6 Hours, any sex, with Neonatal Encephalopathy or Newborn Asphyxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS.

The main questions it aims to answer are:

1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)?
2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds?

Participants will have the following interventions:

* Randomisation into one of the following groups

* Whole body hypothermia group
* Targeted normothermia group
* Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age.

Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Whole-body hypothermia in mild neonatal encephalopathy: protocol for a multicentre phase III randomised controlled trial.
   Garegrat R, Montaldo P, Burgod C, Pant S, et al · · 2024 · cited 5× · PMID 39026197 · DOI 10.1186/s12887-024-04935-4