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An approach to using recombinant erythropoietin for neuroprotection in very preterm infants
Jean-Claude Fauchère1, Christof Dame, Reinhard Vonthein
1Clinic of Neonatology, University Hospital Zurich, Zurich, Switzerland.
Insights
Early high-dose recombinant human erythropoietin administration in very preterm infants showed no significant adverse effects. This finding supports further research into its potential to reduce perinatal brain injury and improve neurodevelopmental outcomes.
Area of Science:
- Neonatal Medicine
- Neuroprotection
- Pharmacology
Background:
- Erythropoietin demonstrates protective effects against hypoxic-ischemic and inflammatory injuries in various models.
- Perinatal brain injury, including intraventricular hemorrhage and periventricular leukomalacia, is a significant concern in very preterm infants.
- The potential of early high-dose recombinant human erythropoietin (rHuEPO) to mitigate these injuries and improve neurodevelopmental outcomes warrants investigation.
Purpose of the Study:
- To assess the safety of early high-dose rHuEPO administration in very preterm infants.
- To evaluate short-term outcomes related to brain injury and other morbidities.
Main Methods:
- A randomized, double-masked, single-center trial was conducted with a 2:1 allocation ratio favoring rHuEPO.
- Very preterm infants (gestational age 24-31 weeks) received either rHuEPO or a 0.9% NaCl placebo intravenously at 3, 12-18, and 36-42 hours post-birth.
Main Results:
- Survival without brain injury or retinopathy was 53% in the rHuEPO group versus 60% in the placebo group.
- No significant differences were observed in short-term outcomes, including intraventricular hemorrhage, retinopathy, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia.
- rHuEPO treatment did not impact blood pressure, cerebral oxygenation, hemoglobin, leukocyte, or platelet counts. However, 5 infants in the rHuEPO group with gestational age <26 weeks required withdrawal of intensive care.
Conclusions:
- Early high-dose rHuEPO treatment in very preterm infants appears safe regarding short-term outcomes.
- The study provides a foundation for a larger multicenter trial to determine if rHuEPO improves long-term neurodevelopmental outcomes at 24 months and 5 years corrected age.
Objective:
Erythropoietin has been shown to be protective against hypoxic-ischemic and inflammatory injuries in cell culture, animal models of brain injury, and clinical trials of adult humans. The rationale for our study was that early administration of high-dose recombinant human erythropoietin may reduce perinatal brain injury (intraventricular hemorrhage and periventricular leukomalacia) in very preterm infants and improve neurodevelopmental outcome. We investigated whether administration of high-dose recombinant human erythropoietin to very preterm infants shortly after birth and subsequently during the first 2 days is safe in terms of short-term outcome.
Methods:
This was a randomized, double-masked, single-center trial with a 2:1 allocation in favor of recombinant human erythropoietin. Preterm infants (gestational age: 24 to 31 weeks) were given recombinant human erythropoietin or NaCl 0.9% intravenously 3, 12 to 18, and 36 to 42 hours after birth.
Results:
The percentage of infants who survived without brain injury or retinopathy was 53% in the recombinant human erythropoietin group and 60% in the placebo group. There were no relevant differences regarding short-term outcomes such as intraventricular hemorrhage, retinopathy, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. For 5 infants who were in the recombinant human erythropoietin group and had a gestational age of <26 weeks, withdrawal of intensive care was decided (3 of 5 with severe bilateral intraventricular hemorrhage, 2 of 5 with pulmonary insufficiency); no infant of the control group died. Recombinant human erythropoietin treatment did not result in significant differences in blood pressure, cerebral oxygenation, hemoglobin, leukocyte, and platelet count.
Conclusions:
No significant adverse effects of early high-dose recombinant human erythropoietin treatment in very preterm infants were identified. These results enable us to embark on a large multicenter trial with the aim of determining whether early high-dose administration of recombinant human erythropoietin to very preterm infants improves neurodevelopmental outcome at 24 months' and 5 years' corrected age.
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