To investigate if rhEPO has a positive effect on MRI/MRA parameters compared to infants with stroke without rhEPO collected from historical data.To investigate if rhEPO (3 dosages of 1000IU/kg/day) for perinatal stroke has no negative side-effects…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Positive effects on MRI/MRA parameters (size of stroke, less Wallerian
degeneration) compared to historical data.
Secondary outcome
Side effects of EPO.
Background summary
Cereral arterial stroke in the perinatal period has an incidence of 1/3000-4000
in newborns. PAS causes abnormal cognitive and neuromotor development and
outcome in 30-57%. This complication is therefore an important 'target' for
therapy for reduction of reduction of braindamage. Recently a study described
adults treated for stroke with rhEPO 900IU/kg, without side-effects, had a
significant better outcome compared to placebo-treated group, without side
effects of rhEPO.
The neuroprotective activity of rhEPO (neurotroph, angiogenesis,
anti-inflammatory, anti-apoptic activity) was already shown in animal
experimental research. It showed that rhEPO is effective in case of global
hypoxic-ischemia as well as focal cerebral ischemia of the middle cerebral
artery with a reduction of the size of the stroke up to 40%. Furthermore, rhEPO
has been clinically used for anemia in preterm born infants, with a dosages
until 700 IU/kg and even higher during a prolonged period of time (4 - 8 wks)
without side effects.
Study objective
To investigate if rhEPO has a positive effect on MRI/MRA parameters compared to
infants with stroke without rhEPO collected from historical data.
To investigate if rhEPO (3 dosages of 1000IU/kg/day) for perinatal stroke has
no negative side-effects on red bloodcell count or clotting system,
bloodpressure, edema.
Study design
All newborn infants with a gestational age of 36 wks admitted to our Neonatal
Intesive Care Unit with the diagnosis perinatal arterial stroke (PAS) diagnosed
with cerebral ultrasound or MRI/MRA. Chormosomal/congenital abnormalities are
exclusion criteria.
Immediately after the diagnosis and parental consent rhEPO (1000IU/kg, iv) will
be given, repeated after 24 h and 48h. Historical data will be used for
comparison.
MRI/MRA will be performed to confirm the diagnosis, this will be repeated after
1 week and after 3 months. This is routine clinical care.
Intervention
Immediately after the diagnosis and parental consent rhEPO (1000IU/kg, iv) will
be given, repeated after 24 h and 48h. Historical data will used as a control
group.
Study burden and risks
MRI/MRA is routine clinical care in patients with PAS.
Extra bloodsample during routine clinical blood withdrawals, for isoprostane,
Non-protein bound iron.
Lundlaan 6
3584 EA Utrecht
NL
Lundlaan 6
3584 EA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Perinatal arterial infarction (PAS) in the brain.
Exclusion criteria
Congenital and/or chromosomal problems.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-002078-71-NL |
CCMO | NL16758.041.07 |