Perinatal Arterial Ischemic Stroke (PAIS)
Conditions
Interventions
Trade Name: Aranesp
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: DARBEPOETIN ALFA
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration t
Sponsors
University Medical Center Utrecht, the Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newborns = 36 weeks gestation, both male and female 2. MRI confirmed diagnosis of acute PAIS , with involvement of the cortical spinal tract (e.g. PLIC or peduncles) 3. Less than 4 days after the onset of clinical symptoms 4. Written informed consent from custodial parent(s) Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Moderate –severe 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To perform a double-blind randomized placebo controlled multicenter study with darbepoetin in infants with MRI confirmed PAIS and to investigate whether darbepoetin can reduce brain injury in neonates who suffered from perinatal arterial ischemic stroke (PAIS). The ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating-agents (ESAs) such as darbepoetin to reduce or even prevent lifelong consequences of PAIS-related brain injury in this group of term newborns. ;Secondary Objective: Not applicable;Primary end point(s): Our 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 and brain growth between the time of onset of the insult and 6-8 weeks of age. Additionally we will assess whether there are differences between darbepoetin and placebo treatment in DTI parameters of selected regions of interest. Primairy endpoints will be estimated using advanced volumetric magnetic resonance (MRI) techniques and diffusion tensor imaging (DTI) MRI techniques, performed within 3 days after clinical presentation and at 6-8 weeks of age.;Timepoint(s) of evaluation of this end point: 6-8 weeks postnatal age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We will assess development of USCP, and cognitive development at 18 months of age using the BSID-III and PSOM scores as well as a full neurological assessment including Gross Motor Function Classification system (GMFCS) and several handfunction tests such as Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and compare them between groups (darbepoetin vs placebo). ;Timepoint(s) of evaluation of this end point: 18 months postnatal age. | — |
Countries
Canada, Netherlands
Contacts
Public ContactManager Research Div. Woman & Baby
University Medical Center Utrecht, the Netherlands
Outcome results
None listed