Darbepoetin for neonatal stroke
- Conditions
- Perinatal Arterial Ischemic Stroke (PAIS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-002997-18-NL
- Lead Sponsor
- niversity Medical Center Utrecht, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
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
- 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