Safety of early high-dose recombinant erythropoietin for neuroprotection in very preterm infants

Journal of Pediatrics

Volumn 167, Issue 1, 2015, Pages 52-57.e3

  Fauchère, Jean Claude ^a   Koller, Brigitte M ^a   Tschopp, Alois ^b   Dame, Christof ^c   Ruegger, Christoph ^a   Bucher, Hans Ulrich ^a   Zeilinger, Georg ^a   Pasquier, Sylviane ^a   Bührer, Christoph ^a  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b UNIVERSITY OF ZURICH   (Switzerland)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOPROTECTIVE AGENT; PLACEBO; RECOMBINANT ERYTHROPOIETIN; ERYTHROPOIETIN; NEUROPROTECTIVE AGENT; RECOMBINANT PROTEIN;

APGAR SCORE; ARTIFICIAL VENTILATION; BRAIN HEMORRHAGE; CONFERENCE PAPER; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; DRUG SAFETY; FEMALE; FOLLOW UP; GESTATIONAL AGE; HEAD CIRCUMFERENCE; HEMATOCRIT; HOSPITALIZATION; HUMAN; INFANT; INVESTIGATIVE PROCEDURES; LEUKOCYTE COUNT; LUNG DYSPLASIA; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NECROTIZING ENTEROCOLITIS; NEUROPROTECTION; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; POSITIVE END EXPIRATORY PRESSURE; PREMATURITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RETICULOCYTE COUNT; RETROLENTAL FIBROPLASIA; SEPSIS; SHORT COURSE THERAPY; THROMBOCYTE COUNT; BRONCHOPULMONARY DYSPLASIA; CLINICAL TRIAL; DEVELOPMENTAL DISABILITIES; DOSE RESPONSE; ENTEROCOLITIS, NECROTIZING; EUROPE; HYPOXIA-ISCHEMIA, BRAIN; INTRACRANIAL HEMORRHAGES; LEUKOMALACIA, PERIVENTRICULAR; NEWBORN; RETINOPATHY OF PREMATURITY;

BRONCHOPULMONARY DYSPLASIA; DEVELOPMENTAL DISABILITIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ENTEROCOLITIS, NECROTIZING; ERYTHROPOIETIN; EUROPE; HEMATOCRIT; HUMANS; HYPOXIA-ISCHEMIA, BRAIN; INFANT, NEWBORN; INFANT, PREMATURE; INTRACRANIAL HEMORRHAGES; LEUKOCYTE COUNT; LEUKOMALACIA, PERIVENTRICULAR; NEUROPROTECTIVE AGENTS; PLATELET COUNT; RECOMBINANT PROTEINS; RETICULOCYTE COUNT; RETINOPATHY OF PREMATURITY; SEPSIS;

EID: 84937525807     PISSN: 00223476     EISSN: 10976833     Source Type: Journal    
DOI: 10.1016/j.jpeds.2015.02.052     Document Type: Conference Paper

References (52)

1. H. Blencowe, S. Cousens, M.Z. Oestergaard, D. Chou, A.B. Moller, R. Narwal, and et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications Lancet 379 2012 2162 2172
2. H.U. Bucher, C. Killer, Y. Ochsner, S. Vaihinger, and J.C. Fauchere Growth, developmental milestones and health problems in the first 2 years in very preterm infants compared with term infants: a population-based study Eur J Pediatr 161 2002 151 156
3. N. Marlow, D. Wolke, M.A. Bracewell, and M. Samara Neurologic and developmental disability at six years of age after extremely preterm birth N Engl J Med 352 2005 9 19
4. R.M. McAdams, and S. Juul Cerebral palsy: prevalence, predictability, and parental counselling Neoreviews 12 2011 e564 e574
5. W. Meadow, G. Lee, K. Lin, and J. Lantos Changes in mortality for extremely low birth weight infants in the 1990s: implications for treatment decisions and resource use Pediatrics 113 2004 1223 1229
6. S. Winter, A. Autry, C. Boyle, and M. Yeargin-Allsopp Trends in the prevalence of cerebral palsy in a population-based study Pediatrics 110 2002 1220 1225
7. T. Moore, E.M. Hennessy, J. Myles, S.J. Johnson, E.S. Draper, K.L. Costeloe, and et al. Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studies BMJ 345 2012 e7961
8. R.L. Haynes, O. Baud, J. Li, H.C. Kinney, J.J. Volpe, and D.R. Folkerth Oxidative and nitrative injury in periventricular leukomalacia: a review Brain Pathol 15 2005 225 233
9. A. Sola, M.R. Rogido, and R. Deulofeut Oxygen as a neonatal health hazard: call for detente in clinical practice Acta Paediatr 96 2007 801 812
10. J.J. Volpe, H.C. Kinney, F.E. Jensen, and P.A. Rosenberg The developing oligodendrocyte: key cellular target in brain injury in the premature infant Int J Dev Neurosci 29 2011 423 440
11. S.E. Jacobs, M. Berg, R. Hunt, W.O. Tarnow-Mordi, T.E. Inder, and P.G. Davis Cooling for newborns with hypoxic ischaemic encephalopathy Cochrane Database Syst Rev 1 2013 CD003311
12. N.J. Robertson, S. Tan, F. Groenendaal, F. van Bel, S.E. Juul, L. Bennet, and et al. Which neuroprotective agents are ready for bench to bedside translation in the newborn infant? J Pediatr 160 2012 544 552.e4
13. P.T. Tsai, J.J. Ohab, N. Kertesz, M. Groszer, C. Matter, J. Gao, and et al. A critical role of erythropoietin receptor in neurogenesis and post-stroke recovery J Neurosci 26 2006 1269 1274
14. M. Chikuma, S. Masuda, T. Kobayashi, M. Nagao, and R. Sasaki Tissue-specific regulation of erythropoietin production in the murine kidney, brain, and uterus Am J Physiol Endocrinol Metab 279 2000 E1242 E1248
15. K. Chin, X. Yu, B. Beleslin-Cokic, C. Liu, K. Shen, H.W. Mohrenweiser, and et al. Production and processing of erythropoietin receptor transcripts in brain Brain Res Mol Brain Res 81 2000 29 42
16. I. Wallach, J. Zhang, A. Hartmann, F.K. van Landeghem, A. Ivanova, M. Klar, and et al. Erythropoietin-receptor gene regulation in neuronal cells Pediatr Res 65 2009 619 624
17. S. Juul, and U. Felderhoff-Mueser Epo and other hematopoietic factors Semin Fetal Neonatal Med 12 2007 250 258
18. C.T. Noguchi, P. Asavaritikrai, R. Teng, and Y. Jia Role of erythropoietin in the brain Crit Rev Oncol Hematol 64 2007 159 171
19. C. Dame, S.E. Juul, and R.D. Christensen The biology of erythropoietin in the central nervous system and its neurotrophic and neuroprotective potential Biol Neonate 79 2001 228 235
20. S. Juul Erythropoietin as a neonatal neuroprotective agent Neoreviews 11 2010 e78 e84
21. S. Juul Neuroprotective role of erythropoietin in neonates J Matern Fetal Neonatal Med 25 Suppl 4 2012 105 107
22. A. Kumral, F. Tuzun, M.G. Oner, S. Genc, N. Duman, and H. Ozkan Erythropoietin in neonatal brain protection: the past, the present and the future Brain Dev 33 2011 632 643
23. R. Bierer, M.C. Peceny, C.H. Hartenberger, and R.K. Ohls Erythropoietin concentrations and neurodevelopmental outcome in preterm infants Pediatrics 118 2006 e635 e640
24. M.S. Brown, D. Eichorst, B. Lala-Black, and R. Gonzalez Higher cumulative doses of erythropoietin and developmental outcomes in preterm infants Pediatrics 124 2009 e681 e687
25. A.P. Neubauer, W. Voss, M. Wachtendorf, and T. Jungmann Erythropoietin improves neurodevelopmental outcome of extremely preterm infants Ann Neurol 67 2010 657 666
26. R.K. Ohls, B.D. Kamath-Rayne, R.D. Christensen, S.E. Wiedmeier, A. Rosenberg, J. Fuller, and et al. Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo Pediatrics 133 2014 1023 1030
27. J.C. Fauchere, C. Dame, R. Vonthein, B. Koller, S. Arri, M. Wolf, and et al. An approach to using recombinant erythropoietin for neuroprotection in very preterm infants Pediatrics 122 2008 375 382
28. S.E. Juul, R.J. McPherson, L.A. Bauer, K.J. Ledbetter, C.A. Gleason, and D.E. Mayock A phase I/II trial of high-dose erythropoietin in extremely low birth weight infants: pharmacokinetics and safety Pediatrics 122 2008 383 391
29. R.H. Leuchter, L. Gui, A. Poncet, C. Hagmann, G.A. Lodygensky, E. Martin, and et al. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age JAMA 312 2014 817 824
30. R.M. McAdams, R.J. McPherson, D.E. Mayock, and S.E. Juul Outcomes of extremely low birth weight infants given early high-dose erythropoietin J Perinatol 33 2013 226 230
31. H. Elmahdy, A.R. El-Mashad, H. El-Bahrawy, T. El-Gohary, A. El-Barbary, and H. Aly Human recombinant erythropoietin in asphyxia neonatorum: pilot trial Pediatrics 125 2010 e1135 e1142
32. Y.W. Wu, L.A. Bauer, R.A. Ballard, D.M. Ferriero, D.V. Glidden, D.E. Mayock, and et al. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics Pediatrics 130 2012 683 691
33. C. Zhu, W. Kang, F. Xu, X. Cheng, Z. Zhang, L. Jia, and et al. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy Pediatrics 124 2009 e218 e226
34. M.J. Benders, N.E. van der Aa, M. Roks, H.L. van Straaten, I. Isgum, M.A. Viergever, and et al. Feasibility and safety of erythropoietin for neuroprotection after perinatal arterial ischemic stroke J Pediatr 164 2014 481 486.e1-2
35. D.B. Andropoulos, K. Brady, R.B. Easley, H.A. Dickerson, R.G. Voigt, L.S. Shekerdemian, and et al. Erythropoietin neuroprotection in neonatal cardiac surgery: a phase I/II safety and efficacy trial J Thorac Cardiovasc Surg 146 2013 124 131
36. H.S. Lee, J. Song, K. Min, Y.S. Choi, S.M. Kim, S.R. Cho, and et al. Short-term effects of erythropoietin on neurodevelopment in infants with cerebral palsy: a pilot study Brain Dev 36 2014 764 769
37. C. Robertson, and S. Sadrameli Erythropoietin in the neurology ICU Curr Treat Options Neurol 15 2013 104 112
38. F. Sanchis-Gomar, J.L. Garcia-Gimenez, H. Pareja-Galeano, M. Romagnoli, C. Perez-Quilis, and G. Lippi Erythropoietin and the heart: physiological effects and the therapeutic perspective Int J Cardiol 171 2014 116 125
39. L.R. Ment, H.S. Bada, P. Barnes, P.E. Grant, D. Hirtz, L.A. Papile, and et al. Practice parameter: neuroimaging of the neonate: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society Neurology 58 2002 1726 1738
40. L.S. De Vries, I.L. Van Haastert, K.J. Rademaker, C. Koopman, and F. Groenendaal Ultrasound abnormalities preceding cerebral palsy in high-risk preterm infants J Pediatr 144 2004 815 820
41. An international classification of retinopathy of prematurity. II. The classification of retinal detachment. The International Committee for the Classification of the Late Stages of Retinopathy of Prematurity Arch Ophthalmol 105 1987 906 912
42. A. Ohlsson, and S.M. Aher Early erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants Cochrane Database Syst Rev 4 2014 CD004863
43. S.M. Aher, and A. Ohlsson Late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants Cochrane Database Syst Rev 4 2014 CD004868
44. K.K. Suk, J.A. Dunbar, A. Liu, N.S. Daher, C.K. Leng, J.K. Leng, and et al. Human recombinant erythropoietin and the incidence of retinopathy of prematurity: a multiple regression model J AAPOS 12 2008 233 238
45. M. Obladen, K. Diepold, and R.F. Maier Venous and arterial hematologic profiles of very low birth weight infants. European Multicenter rhEPO Study Group Pediatrics 106 2000 707 711
46. R.J. McPherson, E.J. Demers, and S.E. Juul Safety of high-dose recombinant erythropoietin in a neonatal rat model Neonatology 91 2007 36 43
47. C. Doege, M. Pritsch, M.C. Fruhwald, and J. Bauer An association between infantile haemangiomas and erythropoietin treatment in preterm infants Arch Dis Child Fetal Neonatal Ed 97 2012 F45 F49
48. R.K. Ohls, R.A. Ehrenkranz, A. Das, A.M. Dusick, K. Yolton, E. Romano, and et al. Neurodevelopmental outcome and growth at 18 to 22 months' corrected age in extremely low birth weight infants treated with early erythropoietin and iron Pediatrics 114 2004 1287 1291
49. H. Kertmen, B. Gurer, E.R. Yilmaz, A.T. Arikok, M.A. Kanat, B.I. Erguder, and et al. The comparative effects of recombinant human erythropoietin and darbepoetin-alpha on cerebral vasospasm following experimental subarachnoid hemorrhage in the rabbit Acta Neurochir (Wien) 156 2014 951 962
50. B. Schmidt, E.V. Asztalos, R.S. Roberts, C.M. Robertson, R.S. Sauve, and M.F. Whitfield Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms JAMA 289 2003 1124 1129
51. Hagmann C, Hüppi PS, Koller BM, Bucher HU, O'Gorman R. Tract-based spatial statistics (TBSS) to address the neuroprotective effect of early erythropoietin on white matter development in preterm infants. Annual Meeting European Society for Paediatric Research ESPR; Porto, October 10-14, 2013. p. A65.
52. H. Ehrenreich, K. Weissenborn, H. Prange, D. Schneider, C. Weimar, K. Wartenberg, and et al. Recombinant human erythropoietin in the treatment of acute ischemic stroke Stroke 40 2009 e647 e656