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Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

NCT03171818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Alberta Children's Hospital

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Manon Benders, MD PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2024-12-31
Completion
2025-06-01
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171818 on ClinicalTrials.gov