Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration (DINOSAUR)

UMC Utrecht

Status and phase: Enrolling; Phase 2

Conditions: PAIS; Perinatal Stroke; Neonatal Stroke

Treatments: Drug: Saline; Drug: Darbepoetin Alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT03171818

NL53975.041.16

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns ≥ 36+0 weeks of gestation, both male and female
• MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule [PLIC] or peduncles) within one week after birth
• Written informed consent from custodial parent(s)

Exclusion criteria

• Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
• Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
• Presence of a serious infection of the central nervous system;
• No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
• Infant for whom withdrawal of supportive care is being considered.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Darbepoetin

Experimental group

Description:

Darbepoetin alfa (Aranesp, Amgen)

Treatment:

Drug: Darbepoetin Alfa

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline