Darbepoetin in Neonatal Encephalopathy Trial
Trial Parameters
Brief 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 2 arm randomised control trial and aims to examine the physiological effects of 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 150 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 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.
Eligibility Criteria
Inclusion Criteria: All the following criteria should be met 1. Babies aged \< 24 hours, gestation age \>36 weeks with a birthweight \>1.8kg. 2. Acute perinatal asphyxia (metabolic acidosis in cord and/or blood gas (pH\<7.0; base deficit \> 16 mmol/L) within first 1 hour of birth). If pH between 7.01 and 7.15, a base deficit between 10 and 15.9 mmol/L, additionally acute obstetric event and either need for continued resuscitation or ventilation at 10 minutes after birth and/or 10 minutes Apgar score \<5 is required. 3. Evidence of mild, moderate, or severe encephalopathy on an NICHD neurological examination performed between 1 and 6 hours of birth. The worst recorded encephalopathy stage between 1 and 6 hours of birth should be used. 4. Cooling therapy initiated for neonatal encephalopathy within 6 hours of age as a part of standard clinical care, with an intention of continuing for 72 hours. Exclusion Criteria: 1. Major life-threatening congenital malformation. 2. Concomitant particip