Using darbepoetin to help newborns recover from ischemic stroke
Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
This study is testing if a medication called darbepoetin can help newborns recover better from a type of stroke by promoting brain healing.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 7 Days |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT03171818 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of darbepoetin, an erythropoiesis-stimulating agent, on newborns diagnosed with perinatal arterial ischemic stroke (PAIS) confirmed by MRI. It is a randomized, double-blind, placebo-controlled trial where infants will receive either darbepoetin or a saline placebo to assess its ability to promote neuronal tissue formation and restore brain function. The ultimate goal is to develop a therapy that can mitigate the long-term consequences of brain injury associated with PAIS in term newborns.
Who should consider this trial
Good fit: Ideal candidates are newborns aged 36 weeks or older with MRI-confirmed acute PAIS involving the middle cerebral artery.
Not a fit: Patients with severe hypoxic-ischemic encephalopathy or major congenital anomalies are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for newborns affected by ischemic strokes.
How similar studies have performed: While the use of darbepoetin in this context is novel, previous studies on erythropoiesis-stimulating agents have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Posterior Limb of Internal Capsule \[PLIC\] or peduncles) within one week after birth * Written informed consent from custodial parent(s) Exclusion Criteria: * Moderate -severe Hypoxic-Ischemic Encephalopathy (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.
Where this trial is running
Utrecht
- Wilhelmina Childrens Hostpital/University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Manon Benders, MD PhD — UMC Utrecht
- Study coordinator: Manon Benders, MD PhD
- Email: m.benders@umcutrecht.nl
- Phone: +31 88 755 5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.