Status:

RECRUITING

Cooling in Mild Encephalopathy

Lead Sponsor:

Imperial College London

Conditions:

Neonatal Encephalopathy

Newborn Asphyxia

Eligibility:

All Genders

1-6 years

Phase:

PHASE3

Brief Summary

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 gui...

Detailed Description

COMET is a phase III prospective multi-centre open label two-arm randomised controlled trial with an internal pilot and masked outcome assessments. Administration of cooling therapy cannot be masked. ...

Eligibility Criteria

Inclusion Criteria:

All babies born at or after 36 weeks of gestation with a birth weight of 1800g or more with birth acidosis or requiring resuscitation at birth will be screened for eligibility.

Parents will be approached for consent if the baby meets all the three (A + B + C) criteria below:

A. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of <6 at 10 minutes after birth; (ii) continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth; (iii) severe birth acidosis defined as any occurrence of pH =<7.00 or a Base deficit >=16mmol/l in any cord or baby gas sample within 60 minutes of birth.

B. Evidence of mild hypoxic ischaemic encephalopathy defined as - two or more abnormal findings in any of the six categories of the modified Sarnat examination (level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system) but not meeting the diagnosis of moderate or severe hypoxic ischaemic encephalopathy on a standardised examination performed by a certified examiner between 1 to 6 hours of age.

C. Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the aEEG activity more than 10 microvolts and the lower margin more than 5 microvolts on a single channel aEEG.

Exclusion Criteria:

  • Infants who meet the BAPM criteria for whole-body hypothermia
  • Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.
  • Infants with major congenital or chromosomal anomalies identified prior to randomisation.
  • Infants with birthweight <1800g.
  • Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.

Key Trial Info

Start Date :

March 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2030

Estimated Enrollment :

426 Patients enrolled

Trial Details

Trial ID

NCT05889507

Start Date

March 15 2024

End Date

January 1 2030

Last Update

February 6 2026

Active Locations (39)

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Page 1 of 10 (39 locations)

1

Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"

Naples, Italy

2

William Harvey Hospital

Ashford, United Kingdom, TN24 0LZ

3

St Peters Hosptial

Ashford, United Kingdom

4

Birmingham Heartlands

Birmingham, United Kingdom