Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT03171818
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2017-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An international multicenter, randomized placebo controlled intervention study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in stroke tissue loss', 'timeFrame': '6-8 weeks of age', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Reorganization of corticospinal connectivity', 'timeFrame': '6-8 weeks of age', 'description': '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.'}, {'measure': 'Neurodevelopment', 'timeFrame': '18 months of age', 'description': '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).'}, {'measure': 'Neurological assessment', 'timeFrame': '18 months of age', 'description': '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.'}, {'measure': 'Development of Cerebral Palsy', 'timeFrame': '18 months of age', 'description': 'Development of Unilateral Spastic Cerebral Palsy (USCP) using the Gross Motor Function Classification system (GMFCS) and compare this between groups (darbepoetin vs placebo).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PAIS', 'Neonatal Stroke', 'Perinatal Stroke']}, 'referencesModule': {'references': [{'pmid': '24321539', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns ≥ 36+0 weeks of gestation, both male and female\n* 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\n* Written informed consent from custodial parent(s)\n\nExclusion Criteria:\n\n* Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy\n* Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;\n* Presence of a serious infection of the central nervous system;\n* No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.\n* Infant for whom withdrawal of supportive care is being considered.'}, 'identificationModule': {'nctId': 'NCT03171818', 'acronym': 'DINOSAUR', 'briefTitle': 'Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration', 'orgStudyIdInfo': {'id': 'NL53975.041.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darbepoetin', 'description': 'Darbepoetin alfa (Aranesp, Amgen)', 'interventionNames': ['Drug: Darbepoetin Alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Darbepoetin Alfa', 'type': 'DRUG', 'otherNames': ['Aranesp'], 'description': 'Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.', 'armGroupLabels': ['Darbepoetin']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Sodium Chloride'], 'description': 'The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 EA', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Manon Benders, MD, PhD', 'role': 'CONTACT', 'phone': '+31(0)887554545'}, {'name': 'Lisanne M Baak, MD', 'role': 'CONTACT', 'email': 'L.M.Baak-3@umcutrecht.nl', 'phone': '+31(0)887554545'}, {'name': 'Linda S de Vries, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manon JN Benders, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nienke Wagenaar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Floris Groenendaal, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeroen Dudink, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisanne M Baak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Niek E van der Aa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adam Kirton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nomazulu Dlamini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wilhelmina Childrens Hostpital/University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Manon Benders, MD PhD', 'role': 'CONTACT', 'email': 'm.benders@umcutrecht.nl', 'phone': '+31 88 755 5555'}, {'name': 'Lisanne M Baak, MD', 'role': 'CONTACT', 'email': 'l.m.baak-3@umcutrecht.nl', 'phone': '+31 88 755 5555'}], 'overallOfficials': [{'name': 'Manon Benders, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': "Alberta Children's Hospital", 'class': 'OTHER'}, {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator UMC Utrecht', 'investigatorFullName': 'dr. M.J.N.L. Benders', 'investigatorAffiliation': 'UMC Utrecht'}}}}