Neonatal Stroke
Conditions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - (Near-)Term infants, *36+0 weeks of gestation, admitted to one of the Dutch NICUs, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms. - PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery - Written informed consent from custodial parent(s)
Exclusion criteria
Exclusion criteria: - Any proven or suspected congenital anomaly, chromosomal disorder, metabolic disorder. - Presence of an infection of the central nervous system. - No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary objective is to determine if MSC treatment reduces brain damage, which will be measured on one hand by the change in lesion size and brain growth between the time of onset of the insult and 3 months of age and on the other hand by change of reorganisation of the sensorimotor cortex after neonatal stroke. Change in lesion size and brain growth will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within 3 days after clinical presentation and at 3 months of age. We will use post-processing fibretracking programs on diffusion tension imaging (DTI) to detect whether MSC treatment stimulates reorganization of the sensorimotor cortex. These MRI-techniches are established within the Imaging Istituut (ISI) of the UMCU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Long term outcome: All infants included in this study will be followed according to our standardized long term follow up studies which includes analysis of the BSID-III score (mental development index (MDI) and psychomotor development index (PDI)) at the corrected age of 24 months. The BSID-III offers a standardized assessment of cognitive and motor development for children aged 1 month through 42 months. The MDI evaluates a variety of abilities: sensory/perceptual acuities, acquisition of object constancy, memory, learning, problem solving, vocalization, beginning of verbal communication, basis of abstract thinking. The gross motor classification system (GMFCS) will be used to assess the level of disabilty in those who do develop USCP and the Manual Abilty Classification System (MACS) will be used to assess hand involvement in more detail, but only at 4 years and beyond. | — |
Countries
Netherlands
Outcome results
None listed