Erythropoietin and Darbepoetin in Neonatal Encephalopathy (EDEN) Trial

• Research type

  Research Study

• Full title

  Erythropoietin and Darbepoetin in Neonatal Encephalopathy (EDEN) study

• IRAS ID

  277361

• Contact name

  Sudhin Thayyil

• Contact email

  s.thayyil@imperial.ac.uk

• Clinicaltrials.gov Identifier

  NCT04432662

• Duration of Study in the UK

  3 years, 11 months, 28 days

• Research summary

  Hypoxic Ischemic Encephalopathy is also known as ‘birth asphyxia related brain injury’ and happens when the brain does not receive enough oxygen or blood flow around the time of birth.
  Birth asphyxia related brain injury is the most common cause of death and neurodisability in term babies.
  Cooling therapy has substantially improved the outcomes of babies with HIE. However, unacceptably high rate of adverse outcomes are still seen in cooled babies with HIE.

  There are 2 studies in the EDEN trial
  Study 1: This study aims to develop a sequence to be able to perform scans and obtain the same results in different types of MR scanners.
  Study 2: Aims to examine the neuroprotective effects of erythropoietin or Darbepoetin therapy in babies with neonatal encephalopathy undergoing cooling therapy by analysing MR results.

  METHODS
  Study 1: Will be conducted at Imperial NHS trust and Imperial College London, recruiting 20 healthy adult volunteers over 2 month. Volunteers will be scanned at 1.5 Telsa and 3Tesla MR scanners, and the sequences will be optimised to obtained comparable results.

  Study 2: Will be conducted in 15neonatal units in the UK over 2 year;7 with 3Tesla MR scanners and 8 with 1.5 Telsa MR scanner, using the optimised MR spectroscopy sequences.
  A total of 120 will be randomised within the first 24 ours of life to:
  •Group 1: Erythropoietin IV along with cooling therapy
  •Group 2: Darbepoetin Alpha along with cooling therapy.
  •Group 3: Cooling only (usual care)

  BENEFITS
  The data from this study will provide key feasibility information for future neuroprotection trials.
  Firstly, the study will inform if multicentric trials using thalamic NAA can be conducted in a setting with both 1.5 Telsa and 3 Tesla MR scanners.
  Secondly, this study will provide a will provide a Go/No Go signal for a subsequent phase II placebo controlled randomised controlled trial to examine the clinical benefits of Epo on neurodevelopmental outcomes in cooled infants with neonatal encephalopathy.

• REC name

  West of Scotland REC 5

• REC reference

  20/WS/0057

• Date of REC Opinion

  27 May 2020

• REC opinion

  Further Information Favourable Opinion