NCT03171818RecruitingPhase 2
Darbepoetin for neonatal stroke
Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Jul 2024
- Start date
- 8 Aug 2024
- Lead sponsor
- Universitair Medisch Centrum Utrecht
- Diseases
- Stroke
- NCT number
- NCT03171818
- EU CT number
- 2024-513042-12-01
- EudraCT number
- 2015-002997-18
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.