Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration "DINOSAUR"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Newborns ≥ 36+0 weeks of gestation, both male and female
- MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule [PLIC] or peduncles) within one week after birth
- Written informed consent from custodial parent(s)

Exclusion Criteria

- Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
- Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
- Presence of a serious infection of the central nervous system;
- No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
- Infant for whom withdrawal of supportive care is being considered.