Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneratio
Phase 3
Recruiting
- Conditions
- Perinatal Arterial Ischemic Stroke (PAIS)Neonatal stroke1000796310028920
- Registration Number
- NL-OMON55870
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
- Newborns >= 36+0 weeks of gestation, both male and female
- MRI confirmed diagnosis of acute PAIS , in the MCA region with involvement of
the cortical spinal tract (e.g. PLIC or peduncles) within one week after the
onset of clinical symptoms
- Written informed consent from custodial parent(s)
Exclusion Criteria
- Moderate -severe HIE with or without hypothermia therapy ;
- Any proven or suspected major congenital anomaly, chromosomal disorder,
metabolic disorder;
- Presence of a serious infection of the central nervous system;
- No realistic prospect of survival, (e.g. severe brain injury), at the
discretion of the attending physician;
- Infant for whom withdrawal of supportive care is being considered.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary objective is to determine whether there is a difference in the<br /><br>degree in stroke tissue loss between darbepoetin and placebo treatment, which<br /><br>will be measured by the change in lesion size between the time of onset of the<br /><br>insult and 6-8 weeks of age. Primairy endpoints will be estimated using<br /><br>advanced volumetric magnetic resonance (MRI) techniques, performed within one<br /><br>week after clinical presentation and at 6-8 weeks of age. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br>- We will assess whether there are differences between darbepoetin and placebo<br /><br>treatment in Diffusion Tensor Imaging (DTI) parameters of selected regions of<br /><br>interest. DTI-MRI techniques are performed within one week after clinical<br /><br>presentation and at 6-8 weeks of age.<br /><br>- We will assess development of USCP, and cognitive development at 18 months of<br /><br>age using the BSID-III scores as well as a full neurological assessment<br /><br>including Gross Motor Function Classification system (GMFCS) and several<br /><br>handfunction tests such as Manual Ability Classification System (MACS), the<br /><br>Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and<br /><br>compare them between groups (darbepoetin vs<br /><br>placebo). </p><br>