treatment of perinatal stroke.
Conditions
Interventions
Trade Name: neorecormon
Product Name: neorecormon 1000IE
Product Code: EU/1/97/031/028
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: epoetinum- alpha-beta
CAS Number: b03xa01
Concentr
Sponsors
Wilhelmina Children's Hospital/UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Congenital and/or chromosomal problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed