Darbepoetin for neonatal stroke
Phase 1
- Conditions
- Perinatal Arterial Ischemic Stroke (PAIS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-513042-12-01
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method