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Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

NCT ID: NCT03171818

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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PAIS Neonatal Stroke Perinatal Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

An international multicenter, randomized placebo controlled intervention study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This will be a double-blinded study, meaning that both the patient (and his/her parents) and the health care providers, including neonatologist, pediatrician, nurses, physiotherapists, etc, are not allowed to know what treatment the patient has been given. Those that collect outcome parameters, such as MRI data and neurodevelopmental outcome, are also unaware of treatment allocation, meaning that blinding will be maintained during the full study-period of 18 months.

Study Groups

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Darbepoetin

Darbepoetin alfa (Aranesp, Amgen)

Group Type EXPERIMENTAL

Darbepoetin Alfa

Intervention Type DRUG

Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.

Interventions

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Darbepoetin Alfa

Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.

Intervention Type DRUG

Saline

The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.

Intervention Type DRUG

Other Intervention Names

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Aranesp Sodium Chloride

Eligibility Criteria

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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.
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Children's Hospital

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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dr. M.J.N.L. Benders

Principal Investigator UMC Utrecht

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manon Benders, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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Wilhelmina Childrens Hostpital/University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Manon Benders, MD PhD

Role: CONTACT

Phone: +31 88 755 5555

Email: [email protected]

Lisanne M Baak, MD

Role: CONTACT

Phone: +31 88 755 5555

Email: [email protected]

Facility Contacts

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Manon Benders, MD, PhD

Role: primary

Lisanne M Baak, MD

Role: backup

References

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Benders MJ, van der Aa NE, Roks M, van Straaten HL, Isgum I, Viergever MA, Groenendaal F, de Vries LS, van Bel F. Feasibility and safety of erythropoietin for neuroprotection after perinatal arterial ischemic stroke. J Pediatr. 2014 Mar;164(3):481-6.e1-2. doi: 10.1016/j.jpeds.2013.10.084. Epub 2013 Dec 8.

Reference Type BACKGROUND
PMID: 24321539 (View on PubMed)

Other Identifiers

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NL53975.041.16

Identifier Type: -

Identifier Source: org_study_id