Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration "DINOSAUR"

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Saline Drug
    Other Names: Sodium Chloride
    Intervention Desc: The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Saline
  • Darbepoetin alfa Drug
    Other Names: Aranesp
    Intervention Desc: Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
    ARM 1: Kind: Experimental
    Label: Darbepoetin
    Description: Darbepoetin alfa (Aranesp, Amgen)

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in stroke tissue loss 6-8 weeks of age
Secondary Reorganization of corticospinal connectivity 6-8 weeks of age
Secondary Neurodevelopment 18 months of age
Secondary Neurological assessment 18 months of age
Secondary Development of Cerebral Palsy 18 months of age

Sponsors