Reductie van Hersenschade na Perinatal Arterial Stroke”of PAS met recombinant humaan Erythropoietine (rhEPO): Een Proof of Concept” en Safety” studie - reduction of braindamage after rhEPO
- Conditions
- treatment of perinatal stroke.
- Registration Number
- EUCTR2007-002078-71-NL
- Lead Sponsor
- Wilhelmina Children's Hospital/UMC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Newborn infants with gestational age more than 36 weeks admitted to the NICU, with diagnosis perinatal arterial stroke (often Middle Cerebral artery) diagnosed with cerebral ultrasound and/or cerebral MRI/MRA .
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Congenital and/or chromosomal problems.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if 3 dosage of 1000 IU/kg/day rhEPO iv, aministered asap after the diagnosis neonatal stroke have no negative side effects on white and red bloodcells, bloodpressure, edema. Furthermore ;Secondary Objective: To investigate if rhEPO has a positive effect on MRI/MRA parameters after administering in the first week.These data will be compared to data MRI/MRA parameters of historical collected patients with neonatal stroke.;Primary end point(s): MRI/MRA parameters: size of segmentations of affected area.
- Secondary Outcome Measures
Name Time Method