Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants (EpoRepair) : a randomized controlled trial : background, aims, and study protocol

Christoph M Rüegger, Cornelia F Hagmann, Christoph Bührer, Leonhard Held, Hans Ulrich Bucher, Sven Wellmann
2015
BACKGROUND: Preterm infants suffering from intraventricular hemorrhage (IVH) are at increased risk for neurodevelopmental impairment. Observational data suggest that recombinant human erythropoietin (rEPO) improves long-term cognitive outcome in infants with IVH. Recent studies revealed a beneficial effect of early high-dose rEPO on white matter development in preterm infants determined by magnetic resonance imaging (MRI). OBJECTIVES: To summarize the current evidence and to delineate the study
more » ... delineate the study protocol of the EpoRepair trial (Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants). METHODS: The study involves a review of the literature and the design of a doubleblind, placebo-controlled, multicenter trial of repetitive high-dose rEPO administration, enrolling 120 very preterm infants with moderate-to-severe IVH diagnosed by cranial ultrasound in the first days of life, qualitative and quantitative MRI at term-equivalent age and long-term neurodevelopmental followup until 5 years of age. RESULTS AND CONCLUSIONS: The hypothesis generated by observational data that rEPO may improve long-term cognitive outcomes of preterm infants suffering from IVH are to be confirmed or refuted by the randomized controlled trial, EpoRepair. pothesis generated by observational data that rEPO may improve long-term cognitive outcomes of preterm infants suffering from IVH are to be confirmed or refuted by the randomized controlled trial, EpoRepair. Fig. 2. Stability of rEPO in plastic syringes. Concentrations of rEPO (Recormon) are plotted to days of storage and are given relative to day 0. Data are presented as box (interquartile range) and whisker (5-95% range) plots. No significant differences were noted between days of storage. Color version available online 80 90 100 110 120 0 1 3 7 Days Relative concentration -EPO (%)
doi:10.5167/uzh-117662 fatcat:zwzg2v37nbbydkat3amxjuq2c4