{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T11:25:42Z","timestamp":1789730742895,"version":"4.0.1"},"reference-count":64,"publisher":"American Academy of Pediatrics (AAP)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2012,10,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE:<\/jats:title>\n                    <jats:p>To determine the safety and pharmacokinetics of erythropoietin (Epo) given in conjunction with hypothermia for hypoxic-ischemic encephalopathy (HIE). We hypothesized that high dose Epo would produce plasma concentrations that are neuroprotective in animal studies (ie, maximum concentration = 6000\u201310\u2009000 U\/L; area under the curve = 117\u2009000\u2013140\u2009000 U*h\/L).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>In this multicenter, open-label, dose-escalation, phase I study, we enrolled 24 newborns undergoing hypothermia for HIE. All patients had decreased consciousness and acidosis (pH &amp;lt; 7.00 or base deficit \u2265 12), 10-minute Apgar score \u2264 5, or ongoing resuscitation at 10 minutes. Patients received 1 of 4 Epo doses intravenously: 250 (N = 3), 500 (N = 6), 1000 (N = 7), or 2500 U\/kg per dose (N = 8). We gave up to 6 doses every 48 hours starting at &amp;lt;24 hours of age and performed pharmacokinetic and safety analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Patients received mean 4.8 \u00b1 1.2 Epo doses. Although Epo followed nonlinear pharmacokinetics, excessive accumulation did not occur during multiple dosing. At 500, 1000, and 2500 U\/kg Epo, half-life was 7.2, 15.0, and 18.7 hours; maximum concentration was 7046, 13\u2009780, and 33\u2009316 U\/L, and total Epo exposure (area under the curve) was 50\u2009306, 131\u2009054, and 328\u2009002 U*h\/L, respectively. Drug clearance at a given dose was slower than reported in uncooled preterm infants. No deaths or serious adverse effects were seen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>Epo 1000 U\/kg per dose intravenously given in conjunction with hypothermia is well tolerated and produces plasma concentrations that are neuroprotective in animals. A large efficacy trial is needed to determine whether Epo add-on therapy further improves outcome in infants undergoing hypothermia for HIE.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1542\/peds.2012-0498","type":"journal-article","created":{"date-parts":[[2012,9,24]],"date-time":"2012-09-24T20:27:03Z","timestamp":1348518423000},"page":"683-691","source":"Crossref","is-referenced-by-count":178,"title":["Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics"],"prefix":"10.1542","volume":"130","author":[{"given":"Yvonne W.","family":"Wu","sequence":"first","affiliation":[{"name":"Departments of Neurology,"},{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry A.","family":"Bauer","sequence":"additional","affiliation":[{"name":"Pharmacy, University of Washington, Seattle, Washington;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberta A.","family":"Ballard","sequence":"additional","affiliation":[{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna M.","family":"Ferriero","sequence":"additional","affiliation":[{"name":"Departments of Neurology,"},{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David V.","family":"Glidden","sequence":"additional","affiliation":[{"name":"Epidemiology and Biostatistics, University of California, San Francisco, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis E.","family":"Mayock","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taeun","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Children\u2019s National Medical Center, Washington, DC;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Durand","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Children\u2019s Hospital Oakland, Oakland, California; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongli","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Santa Clara Valley Medical Center, San Jose, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia L.","family":"Bonifacio","sequence":"additional","affiliation":[{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando F.","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah C.","family":"Glass","sequence":"additional","affiliation":[{"name":"Departments of Neurology,"},{"name":"Pediatrics, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra E.","family":"Juul","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2012,10,1]]},"reference":[{"issue":"6","key":"2021120900272047100_B1","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1016\/j.earlhumdev.2010.05.010","article-title":"Epidemiology of neonatal encephalopathy and hypoxic-ischaemic encephalopathy.","volume":"86","author":"Kurinczuk","year":"2010","journal-title":"Early Hum Dev"},{"issue":"6","key":"2021120900272047100_B2","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1016\/j.ajog.2008.06.094","article-title":"A systematic review of the role of intrapartum hypoxia-ischemia in the causation of neonatal encephalopathy.","volume":"199","author":"Graham","year":"2008","journal-title":"Am J Obstet 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