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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
Sponsor:
Collaborators:
Alberta Children's Hospital
The Hospital for Sick Children
Information provided by (Responsible Party):
dr. M.J.N.L. Benders, UMC Utrecht

Brief 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.

Condition or disease Intervention/treatment Phase
PAIS Neonatal Stroke Perinatal Stroke Drug: Darbepoetin Alfa Drug: Saline Phase 2

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Darbepoetin
Darbepoetin alfa (Aranesp, Amgen)
Drug: Darbepoetin Alfa
Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
Other Name: Aranesp

Placebo Comparator: Placebo
Saline
Drug: Saline
The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
Other Name: Sodium Chloride




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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         
Sponsors and Collaborators
UMC Utrecht
Alberta Children's Hospital
The Hospital for Sick Children
Investigators
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Principal Investigator: Manon Benders, MD PhD UMC Utrecht
Publications:
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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

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Darbepoetin alfa
Hematinics