Cooling in Mild Encephalopathy

• Research type

  Research Study

• Full title

  Optimal duration of Cooling therapy in Mild Encephalopathy (COMET 1)

• IRAS ID

  241031

• Contact name

  Sudhin Thayyil

• Contact email

  s.thayyil@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Approximately one million full term babies die and an equivalent number become disabled for life every year as a result of birth asphyxia related brain injury. Although cooling the body to 33.5°C for 72 hours benefits babies who have severe forms of brain injury, most babies have milder forms of brain injury (i.e. mild encephalopathy).

  1. To examine the feasibility of recruiting and randomising babies with mild neonatal encephalopathy to multiple treatment durations.
  2. To examine the feasibility of obtaining adequate quality data on the primary outcome for the phase II trial (i.e. thalamic N-acetyl aspartate level) in the recruited babies
  3. To examine the feasibility of collecting adequate quality data for exploratory sub-studies on heart rate variability and gene expression profile

  METHODS
  A total of 32 babies with mild neonatal encephalopathy will be recruited from several large hospitals in the UK, and will be randomised to normothermia (36 to 36.5C) or whole-body cooling for one of three durations: 24h, 48h, or 72h followed by rewarming at 0.5C per hour. We will collect 0.5 ml of venous or arterial blood at the time of recruitment (aged <6 hours) and again at 80 hours of age. All babies will have continuous ECG and aEEG recording as part of the intensive care for at-least 72 hours. The thalamic concentration of N-acetyl-aspartate, [NAA], will be measured using 3 Tesla magnetic resonance (MR) spectroscopy performed between 4 and 7 days after birth.

  DATA ANALYSIS AND OUTCOME MEASURES
  • Proportion of the eligible babies recruited and the realistic recruitment rates per centre
  • Number of babies with adequate quality data on thalamic NAA levels.

  This feasibility study will inform the design of a phase II RCT of cooling in mild encephalopathy.

• REC name

  West of Scotland REC 5

• REC reference

  18/WS/0087

• Date of REC Opinion

  13 Jun 2018

• REC opinion

  Further Information Favourable Opinion