Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration (DINOSAUR)
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ClinicalTrials.gov Identifier: NCT03171818 |
Recruitment Status :
Recruiting
First Posted : May 31, 2017
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
PAIS Neonatal Stroke Perinatal Stroke | Drug: Darbepoetin Alfa Drug: Saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | An international multicenter, randomized placebo controlled intervention study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | October 1, 2021 |
Estimated Study Completion Date : | April 1, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Darbepoetin
Darbepoetin alfa (Aranesp, Amgen)
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Drug: Darbepoetin Alfa
Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
Other Name: Aranesp |
Placebo Comparator: Placebo
Saline
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Drug: Saline
The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
Other Name: Sodium Chloride |
- Change in stroke tissue loss [ Time Frame: 6-8 weeks of age ]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.
- Reorganization of corticospinal connectivity [ Time Frame: 6-8 weeks of age ]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.
- Neurodevelopment [ Time Frame: 18 months of age ]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).
- Neurological assessment [ Time Frame: 18 months of age ]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.
- Development of Cerebral Palsy [ Time Frame: 18 months of age ]Development of Unilateral Spastic Cerebral Palsy (USCP) using the Gross Motor Function Classification system (GMFCS) and compare this between groups (darbepoetin vs placebo).

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Ages Eligible for Study: | up to 7 Days (Child) |
Sexes Eligible for Study: | 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171818
Contact: Manon Benders, MD PhD | +31 88 755 5555 | m.benders@umcutrecht.nl | |
Contact: Nienke Wagenaar, MD | +31 88 755 5555 | n.wagenaar@umcutrecht.nl |
Netherlands | |
Wilhelmina Childrens Hostpital/University Medical Center Utrecht | Recruiting |
Utrecht, Netherlands, 3584 EA | |
Contact: Manon Benders, MD, PhD +31(0)887554545 | |
Contact: Nienke Wagenaar, MD +31(0)887554545 ext 63630 n.wagenaar@umcutrecht.nl | |
Principal Investigator: Linda S de Vries, MD, PhD | |
Principal Investigator: Manon JN Benders, MD, PhD | |
Sub-Investigator: Nienke Wagenaar, MD | |
Sub-Investigator: Floris Groenendaal, MD, PhD | |
Sub-Investigator: Jeroen Dudink, MD, PhD |
Principal Investigator: | Manon Benders, MD PhD | UMC Utrecht |
Responsible Party: | dr. M.J.N.L. Benders, Principal Investigator UMC Utrecht, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT03171818 |
Other Study ID Numbers: |
NL53975.041.16 |
First Posted: | May 31, 2017 Key Record Dates |
Last Update Posted: | November 13, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Darbepoetin alfa Hematinics |