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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03171818
Study type Interventional
Source UMC Utrecht
Contact Manon Benders, MD PhD
Phone +31 88 755 5555
Email m.benders@umcutrecht.nl
Status Recruiting
Phase Phase 2
Start date July 1, 2017
Completion date June 1, 2025

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