RESUMO
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.
Assuntos
Deficiências do Desenvolvimento/prevenção & controle , Eritropoetina/administração & dosagem , Recém-Nascido Prematuro , Fármacos Neuroprotetores/administração & dosagem , Displasia Broncopulmonar/epidemiologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Enterocolite Necrosante/epidemiologia , Europa (Continente)/epidemiologia , Hematócrito , Humanos , Hipóxia-Isquemia Encefálica/epidemiologia , Recém-Nascido , Hemorragias Intracranianas/epidemiologia , Contagem de Leucócitos , Leucomalácia Periventricular/epidemiologia , Contagem de Plaquetas , Proteínas Recombinantes/administração & dosagem , Contagem de Reticulócitos , Retinopatia da Prematuridade/epidemiologia , Sepse/epidemiologiaRESUMO
OBJECTIVE: In view of growing concerns regarding the optimal supplementation of oxygen at birth, we measured cerebral oxygenation during the first minutes of life. STUDY DESIGN: Using near-infrared spectroscopy, changes in cerebral oxygenated hemoglobin (O(2)Hb), dexoxygenated hemoglobin (HHb), and tissue oxygenation index (TOI) were measured during the first 15 minutes of life in 20 healthy newborn infants delivered at term by elective cesarean section. RESULTS: O(2)Hb and TOI increased rapidly within the first minutes of life (median slope for O(2)Hb, 3.4 micromol/L/min; range, 1.4 to 20.6 micromol/L/min; median slope for TOI, 4.2 %/min; range, -0.4 to 27.3%/min), and cerebral HHb decreased (median slope, -4.8 micromol/L/min; range, -0.2 to -20.6 micromol/L/min). O(2)Hb, TOI, and HHb all reached a plateau within 8 minutes. CONCLUSIONS: A significant increase in cerebral O(2)Hb and TOI and a significant decrease in HHb occur during immediate adaptation in healthy term newborns, reaching a steady plateau at around 8 minutes after birth.