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Safety and Short-term Outcomes of High-Dose Erythropoietin in Preterm Infants With Intraventricular Hemorrhage: The
Sven Wellmann1,2, Cornelia F Hagmann3,4, Stefanie von Felten5
1Department of Neonatology, University Children's Hospital Regensburg, Hospital St Hedwig of the Order of St John, University of Regensburg, Regensburg, Germany.
Insights
High-dose erythropoietin did not impact brain injury scores in preterm infants with intraventricular hemorrhage (IVH). While not statistically significant, mortality was higher in the erythropoietin group, warranting further investigation.
Area of Science:
- Neonatal medicine
- Pediatric neurology
- Clinical pharmacology
Background:
- Intraventricular hemorrhage (IVH) is a significant cause of death and disability in preterm infants.
- Currently, no specific medical treatments exist for IVH in this vulnerable population.
Purpose of the Study:
- To evaluate the safety and short-term outcomes of administering high-dose erythropoietin to preterm infants diagnosed with IVH.
- To assess the impact of erythropoietin on brain injury as visualized by magnetic resonance imaging.
Main Methods:
- A randomized, double-blind clinical trial involving 121 preterm infants with moderate to severe IVH.
- Infants received either high-dose intravenous erythropoietin (2000 units/kg) or a placebo at four time points within the first four weeks of life.
- Brain MRI scans were performed at term-equivalent age (TEA) to assess brain injury.
Main Results:
- No significant differences in global or regional brain injury scores were observed between the erythropoietin and placebo groups via conventional MRI at TEA.
- The erythropoietin group experienced higher mortality (16.7%) compared to the placebo group (8.2%), though this difference was not statistically significant.
- Infants treated with erythropoietin showed higher mean hematocrit levels.
Conclusions:
- High-dose erythropoietin administration did not demonstrate a benefit in reducing brain injury in preterm infants with IVH, based on MRI findings at TEA.
- The observed trend of increased mortality in the erythropoietin group requires further evaluation in future studies.
- The study highlights the need for continued research into effective treatments for IVH in preterm neonates.
Importance:
Intraventricular hemorrhage (IVH) is a major cause of neonatal morbidity and mortality in preterm infants without a specific medical treatment to date.
Objective:
To assess the safety and short-term outcomes of high-dose erythropoietin in preterm infants with IVH.
Design, Setting, And Participants:
Between April 1, 2014, and August 3, 2018, a randomized double-blind clinical trial enrolled 121 preterm infants (gestational age <32 weeks or birth weight <1500 g) aged 8 or less days with moderate to severe IVH identified by cerebral ultrasonography from 8 Swiss and Austrian tertiary neonatal units. Statistical analyses were performed between October 1, 2019, and September 12, 2022.
Interventions:
Infants received intravenous high-dose erythropoietin (2000 units/kg body weight) or placebo at 4 time points between weeks 1 and 4 of life.
Main Outcomes And Measures:
Secondary outcomes included (1) mortality and morbidity rates and (2) brain magnetic resonance imaging findings at term-equivalent age (TEA). The primary outcome was the composite intelligence quotient at 5 years of age (not available before 2023).
Results:
Sixty infants (48% male [n = 29]) were randomly assigned to receive erythropoietin, and 61 infants (61% male [n = 37]) were randomly assigned to receive placebo. The median birth weight was 832 g (IQR, 687-990 g) in the erythropoietin group and 870 g (IQR, 680-1110 g) in the placebo group. Median gestation was 26.1 weeks (IQR, 24.8-27.3 weeks) in the erythropoietin group and 27.0 weeks (24.9-28.1 weeks) in the placebo group. The 2 groups had similar baseline characteristics and morbidities. Up to TEA, 10 newborns died (16.7%) in the erythropoietin group, and 5 newborns (8.2%) died in the placebo group (adjusted odds ratio, 2.24 [95% CI, 0.74-7.66]; P = .15). Infants receiving erythropoietin had higher mean hematocrit levels. Conventional magnetic resonance imaging at TEA for 100 infants showed no significant differences in global or regional brain injury scores.
Conclusions And Relevance:
This preliminary report of a randomized clinical trial found no evidence that high-dose erythropoietin in preterm infants with IVH affects brain injury scores on conventional magnetic resonance imaging at TEA. Higher mortality in the erythropoietin group was not significant but should be reassessed based on future results from similar trials.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02076373.
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