Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to perform a randomized double-blind placebo controlled prospective
study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial
Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous
administered darbepoetin can induce the formation of neuronal tissue and restore brain
function in neonates who suffered from PAIS compared to placebo treated controls. The
ultimate goal of this study is therefore to develop a therapy using
erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent
lifelong consequences of PAIS-related brain injury in this group of term newborns.
Phase:
Phase 2
Details
Lead Sponsor:
UMC Utrecht
Collaborators:
Alberta Children's Hospital The Hospital for Sick Children