Darbepoetin for neonatal stroke
Key facts
- Where
- Utrecht, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Utrecht
- Trial code
- NCT03171818EU 2024-513042-12-01
- Record updated
- 8 August 2024
- Original description
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.Read full original descriptionShow less
Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
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.
Inclusion: Newborns ≥ 36 weeks gestation, both male and female 2. MRI confirmed diagnosis of acute PAIS , with involvement. 4. Written informed consent from custodial parent(s) of the cortical spinal tract (e.g. PLIC or peduncles) 3. Less than 4 days after the onset of clinical symptoms.
Exclusion: 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.