Safety of Early High-Dose Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants.
J Pediatr
; 167(1): 52-7.e1-3, 2015 Jul.
Article
em En
| MEDLINE
| ID: mdl-25863661
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Recém-Nascido Prematuro
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Deficiências do Desenvolvimento
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Eritropoetina
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Fármacos Neuroprotetores
Tipo de estudo:
Clinical_trials
Limite:
Humans
/
Newborn
País/Região como assunto:
Europa
Idioma:
En
Revista:
J Pediatr
Ano de publicação:
2015
Tipo de documento:
Article
País de publicação:
Estados Unidos