RecruitingNCT03171818DINOSAURUpdated Dec 7, 2023

Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

A Phase 2 interventional study of Darbepoetin Alfa and Saline in PAIS, Neonatal Stroke and Perinatal Stroke, sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by UMC Utrecht · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
Started Jul 2017; still recruiting 9 years 3 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: Up to 7 Days
Sex: All

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 studied

PAIS
Neonatal Stroke
Perinatal Stroke

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Stroke 7,283

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 7 Days
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 80 participants (estimated)

Study arms

Experimental
Darbepoetin
Darbepoetin alfa (Aranesp, Amgen)
Drug: Darbepoetin Alfa
Placebo comparator
Placebo
Saline
Drug: Saline

Interventions

DrugDarbepoetin Alfa
Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
Also known as: Aranesp
DrugSaline
The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
Also known as: Sodium Chloride

What researchers measure

Primary outcomes

Change in stroke tissue loss
The primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size between the time of onset of the insult and 6-8 weeks of age. The primary endpoint will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within one week after clinical presentation and at 6-8 weeks of age.
Time frame: 6-8 weeks of age

Secondary outcomes

Reorganization of corticospinal connectivity
To assess whether there are differences between darbepoetin and placebo treatment in Diffusion Tensor Imaging (DTI) parameters of selected regions of interest. DTI-MRI techniques are performed at 6-8 weeks of age.
Time frame: 6-8 weeks of age
Neurodevelopment
To assess cognitive and motor development at 18 months of age using the Bayley Scales of Infants and Toddler Development (BSITD)-III scores compare them between groups (darbepoetin vs placebo).
Time frame: 18 months of age
Neurological assessment
To assess neurological deficit and function using the Pediatric Stroke Outcome Measure (PSOM) and compare this score between groups (darbepoetin vs placebo). The PSOM is performed at 18 months of age.
Time frame: 18 months of age
Development of Cerebral Palsy
Development of Unilateral Spastic Cerebral Palsy (USCP) using the Gross Motor Function Classification system (GMFCS) and compare this between groups (darbepoetin vs placebo).
Time frame: 18 months of age

Study locations

1 of 1 sites recruiting

Wilhelmina Childrens Hostpital/University Medical Center Utrecht
Utrecht, 3584 EA, Netherlands
- Manon Benders, MD, PhD · Contact · +31(0)887554545
- Lisanne M Baak, MD · Contact · L.M.Baak-3@umcutrecht.nl · +31(0)887554545
- Linda S de Vries, MD, PhD · Principal investigator
- Manon JN Benders, MD, PhD · Principal investigator
- Nienke Wagenaar, MD · Sub investigator
- Floris Groenendaal, MD, PhD · Sub investigator
- Jeroen Dudink, MD, PhD · Sub investigator
- Lisanne M Baak, MD · Sub investigator
- Niek E van der Aa, MD, PhD · Principal investigator
- Adam Kirton, MD, PhD · Principal investigator
- Nomazulu Dlamini, MD, PhD · Principal investigator
Recruiting

References and documents

Publications

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. PubMed 24321539 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03171818
Lead sponsor: UMC Utrecht
Collaborators: Alberta Children's Hospital, The Hospital for Sick Children
Responsible party: dr. M.J.N.L. Benders (Principal Investigator UMC Utrecht, UMC Utrecht) — Principal investigator
First posted: May 31, 2017
Start date: Jul 1, 2017
Primary completion: Dec 31, 2024 (estimated)
Completion: Jun 1, 2025 (estimated)
Last update: Dec 7, 2023

Study contacts

Manon Benders, MD PhD

Contact

m.benders@umcutrecht.nl

+31 88 755 5555

Lisanne M Baak, MD

Contact

l.m.baak-3@umcutrecht.nl

+31 88 755 5555

Manon Benders, MD PhD

principal investigator · UMC Utrecht

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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