Background Erythropoietin has been shown to be protective against hypoxic-ischaemic and inflammatory injuries in cell culture, animal models of brain injury, and in clinical trials in human adults. A multicentre randomized placebo-controlled trial was started to investigate whether early administration of high dose recombinant human erythropoietin (rhEpo) in very preterm infants improves neuro-developmental outcome at 24 months.
Aim Interim analysis of neonatal complications until discharge from hospital.
Results 395 preterm infants were recruited in 5 centres. 206 infants had received (n t ) 3,000 U/kg body weight rhEpo, and 189 infants NaCl 0.9% intravenously at 3, 12–18 and 36–42 hours after birth.
Conclusions No significant adverse effects of early high-dose rhEpo treatment in very preterm infants were identified. The neuroprotective effect will be evaluated in 24 months.