Jean-Claude Fauchère1, Brigitte M Koller2, Alois Tschopp3, Christof Dame4, Christoph Ruegger2, Hans Ulrich Bucher2. 1. Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. Electronic address: jean-claude.fauchere@usz.ch. 2. Division of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. 3. Division of Biostatistics, Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland. 4. Department of Neonatology, Charité-Universitätsmedizin, Berlin, Germany.
Abstract
OBJECTIVE: To investigate the safety and short term outcome of high dose recombinant human erythropoietin (rhEpo) given shortly after birth and subsequently over the first 2 days for neuroprotection to very preterm infants. STUDY DESIGN: Randomized, double masked phase II trial. Preterm infants (gestational age 26 0/7-31 6/7 weeks) were given rhEpo (nt = 229; 3000 U/kg body weight) or NaCl 0.9% (nc = 214) intravenously at 3, 12-18, and 36-42 hours after birth. RESULTS: There were no relevant differences between the groups for short-term outcomes such as mortality, retinopathy of prematurity, intraventricular hemorrhage, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. At day 7-10, we found significantly higher hematocrit values, reticulocyte, and white blood cell counts, and a lower platelet count in the rhEpo group. CONCLUSIONS: Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00413946.
RCT Entities:
OBJECTIVE: To investigate the safety and short term outcome of high dose recombinant humanerythropoietin (rhEpo) given shortly after birth and subsequently over the first 2 days for neuroprotection to very preterm infants. STUDY DESIGN: Randomized, double masked phase II trial. Preterm infants (gestational age 26 0/7-31 6/7 weeks) were given rhEpo (nt = 229; 3000 U/kg body weight) or NaCl 0.9% (nc = 214) intravenously at 3, 12-18, and 36-42 hours after birth. RESULTS: There were no relevant differences between the groups for short-term outcomes such as mortality, retinopathy of prematurity, intraventricular hemorrhage, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. At day 7-10, we found significantly higher hematocrit values, reticulocyte, and white blood cell counts, and a lower platelet count in the rhEpo group. CONCLUSIONS: Early high-dose rhEpo administration to very premature infants is safe and causes no excess in mortality or major adverse events. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00413946.
Authors: Robin K Ohls; Daniel C Cannon; John Phillips; Arvind Caprihan; Shrena Patel; Sarah Winter; Michael Steffen; Ronald A Yeo; Richard Campbell; Susan Wiedmeier; Shawna Baker; Sean Gonzales; Jean Lowe Journal: Pediatrics Date: 2016-02-15 Impact factor: 7.124
Authors: Shenandoah Robinson; Christopher J Corbett; Jesse L Winer; Lindsay A S Chan; Jessie R Maxwell; Christopher V Anstine; Tracylyn R Yellowhair; Nicholas A Andrews; Yirong Yang; Laurel O Sillerud; Lauren L Jantzie Journal: Exp Neurol Date: 2017-12-26 Impact factor: 5.330