Perinatal Arterial Ischemic Stroke (PAIS)
Conditions
Brief summary
Our primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size and brain growth between the time of onset of the insult and 6-8 weeks of age. Additionally we will assess whether there are differences between darbepoetin and placebo treatment in DTI parameters of selected regions of interest.
Detailed description
We will assess development of USCP, and cognitive development at 18 months of age using the BSID-III and PSOM scores as well as a full neurological assessment including Gross Motor Function Classification system (GMFCS) and several handfunction tests such as Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and compare them between groups (darbepoetin vs placebo).
Interventions
DRUGAranesp 10 micrograms solution for injection in pre-filled syringe
DRUGSaline: a solution of sterile normal saline containing 9.0 grams of sodium chloride (NaCl
DRUGtable salt) per liter (0.90%).
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size and brain growth between the time of onset of the insult and 6-8 weeks of age. Additionally we will assess whether there are differences between darbepoetin and placebo treatment in DTI parameters of selected regions of interest. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will assess development of USCP, and cognitive development at 18 months of age using the BSID-III and PSOM scores as well as a full neurological assessment including Gross Motor Function Classification system (GMFCS) and several handfunction tests such as Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and compare them between groups (darbepoetin vs placebo). | — |
Countries
Netherlands
Outcome results
None listed