Erythropoietin and Darbepoetin in Neonatal Encephalopathy Trial
Status:
Not yet recruiting
Trial end date:
2023-09-02
Target enrollment:
Participant gender:
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.
The EDEN trial is a 3 arm randomised control trial and aims to examine the physiological
effects of erythropoietin (Epo) and Darbepoetin alfa (Darbe) therapy on proton magnetic
resonance spectroscopy thalamic N-acetylaspartate (NAA) level in babies with neonatal
encephalopathy undergoing cooling therapy.
A total of 220 babies with neonatal encephalopathy will be recruited from the participating
sites in UK over a 24 month period. The babies will be randomly allocated to erythropoietin,
darbepoetin or usual care. MR imaging and spectroscopy will be performed at 1 to 2 weeks of
age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of
age.