NCT03171818

Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• PAIS
• Neonatal Stroke
• Perinatal Stroke

Interventions

Type	Name	Description
DRUG	Darbepoetin Alfa	Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
DRUG	Saline	The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.

Timeline

• Start date: 2017-07-01
• Primary completion: 2024-12-31
• Completion: 2025-06-01
• First posted: 2017-05-31
• Last updated: 2023-12-07

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study