High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage, Periventricular Leukomalacia, Neurodevelopmental Outcomes, Randomized Clinical Trial
In brief
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.
Key facts
- Study ID
- NCT00589953
- Run by
- Atlantic Health System
- People needed
- 22
- Starts
- 2007-07-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2013-07-30
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 500 to 1250 grams at birth
- Less than 32 weeks gestation at birth
- Less than 24 hours of life at time of enrollment
You may not qualify if…
- Congenital anomalies (chromosomal, CNS, cardiac, GI, pulmonary)
- Seizures within first 24 hours of life
- Severe neutropenia (ANC < 500 cells/microL) within first 24 hours of life
- Polycythemia (Hct > 65%) within first 24 hours of life
- Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
- Hypertension (SBP > 100mmHg) without vasopressor support within first 24 hours of life
Where it is running
- Morristown Medical Center — Morristown, New Jersey, United States
Full record on ClinicalTrials.gov
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