Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics

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 = 6000-10...

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Published in:Pediatrics (Evanston) 2012-10, Vol.130 (4), p.683-691
Main Authors: WU, Yvonne W, BAUER, Larry A, GONZALEZ, Fernando F, GLASS, Hannah C, JUUL, Sandra E, BALLARD, Roberta A, FERRIERO, Donna M, GLIDDEN, David V, MAYOCK, Dennis E, CHANG, Taeun, DURAND, David J, DONGLI SONG, BONIFACIO, Sonia L
Format: Article
Language:English
Subjects:
Analysis of Variance
Biological and medical sciences
Brain diseases
Care and treatment
Combined Modality Therapy
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug dosages
Encephalopathy
Erythropoietin
Erythropoietin - adverse effects
Erythropoietin - blood
Erythropoietin - pharmacokinetics
Erythropoietin - therapeutic use
Female
General aspects
Glycoproteins
Half-Life
Health aspects
Humans
Hypothermia, Induced
Hypoxia-Ischemia, Brain - drug therapy
Hypoxia-Ischemia, Brain - therapy
Infant, Newborn
Infusions, Intravenous
Male
Medical sciences
Metabolic Clearance Rate
Neurology
Neuroprotective Agents - adverse effects
Neuroprotective Agents - blood
Neuroprotective Agents - pharmacokinetics
Neuroprotective Agents - therapeutic use
Pediatric neurology
Pediatrics
Pharmacology
Treatment outcome
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Summary: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 = 6000-10000 U/L; area under the curve = 117000-140000 U*h/L). 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 < 7.00 or base deficit ≥ 12), 10-minute Apgar score ≤ 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
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.2012-0498