NCT01378273

Trial name or title	Preterm Erythropoietin Neuroprotection Trial (PENUT Trial) (PENUT)
Methods	Randomised controlled trial
Participants	Preterm infants 24 0/7 to 27 6/7 weeks' gestation, beginning in the first 24 hours after birth
Interventions	Experimental: EPO 1000 U/kg followed by 400 U/kg. Participants will receive 6 doses of intravenous EPO 1000 U/kg/dose at 48‐hour intervals from the time of enrolment. Following the high‐dose period, participants will receive subcutaneous EPO 400 U/kg/dose 3 times a week until 32 6/7 weeks' postmenstrual age.
Outcomes	Primary outcome measures: neurodevelopmental outcome [Time Frame: 24 to 26 months' corrected age], neurodevelopmental exam Bayley‐III: MDI and PDI Secondary outcome measures: safety [Time Frame: term PMA]. Safety of EPO treatment will be assessed by comparing adverse events and co morbidities between groups. Imaging [Time Frame: 24 to 26 months] MRI at 36 weeks' PMA will be used as a biomarker of long‐term outcomes. Biomarkers [Time Frame: 24 to 26 months of age] Circulating bio markers of inflammation and brain injury will be evaluated and correlated with neurodevelopmental outcomes. Placebo comparator: Control participants will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48‐hour intervals from the time of enrolment. Following high‐dose administration, sham subcutaneous injections will be given 3 times a week through to 32 6/7 weeks' postmenstrual age.
Starting date	December 2013
Contact information	Sandra Juul, Professor of Pediatrics, University of Washington
Notes	NCT01378273