Erythropoietin Did Not Improve Neurodevelopment in Very Preterm Infants

MedicalResearch.com Interview with:
PD Dr. med. Giancarlo Natalucci

OberarztKlinik für Neonatologie
UniversitätsSpital Zürich

MedicalResearch.com: What is the background for this study?

Dr. Natalucci:: Survival of very preterm infants has increased over the last decades but still they are at risk of developing long-term neurodevelopmental delay. The underlying pathology is termed encephalopathy of prematurity where both structural lesions of the very fragile brain and the disturbance of the physiologic maturational processes are recognized as the main causative entities. Among many pharmacological candidates to prevent brain injury and improve development, erythropoietin has been shown to be among the most promising.

MedicalResearch.com: What are the main findings?

Dr. Natalucci: Among very preterm infants born between 26 weeks 0 days and 31 weeks 6 days gestation who received prophylactic early high-dose rhEPO for neuroprotection, compared with infants who received placebo, there were no significant differences in neurodevelopmental outcomes at 2 years.

MedicalResearch.com: What should clinicians and patients take away from your report? 

Dr. Natalucci: Recent evidence form preclinical and clinical studies suggests a role of EPO in neurological tissue development and protection. However, to date still there is not enough evidence to support the administration of rhEPO in the very preterm infants for a neuroprotective purpose.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Natalucci:  Our future research is focusing on the assessment of the neurodevelopmental outcome of the study cohort at school age, as a probably better measure of efficacy, when the children’s cognitive performances become more differentiated than at 2 years. Future research will focus on different rhEPO administration strategies than that of our study [2 large randomized control trials – NCT02036073 and NCT01378273 – have been designed to analyze the neuroprotective role of rhEPO in very preterm infants].

MedicalResearch.com: Is there anything else you would like to add? 

Dr. Natalucci: In our study, both the rhEPO and the placebo group scored considerably higher MDI (mental development index as assessed by the Bayley scales of infant development – 2. Ed.) than previously hypothesized in the planning phase. This might have been possible because preterm infants at a particular high risk for neurodevelopmental impairment were underrepresented within the study participants but also because a constant improvement in the neurodevelopmental outcome of extreme preterm infants has been effectively observed in Switzerland over the last, which is a very positive aspect.

Citation:

Natalucci G, Latal B, Koller B, et al. Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Years: A Randomized Clinical Trial. JAMA.2016;315(19):2079-2085. doi:10.1001/jama.2016.5504.

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