Table 1.

Global clinical trials looking at effect of recombinant Epo and its analogues in neonatal brain diseases affecting both preterm and term infants. These trials are currently active, recruiting or recently completed. They are taken from www.clinicaltrials.gov.

Target population	Trial	Investigator and site	Phase	Study design	NCT	Drug	Drug dosing	Primary outcome
Perinatal asphyxia	Neuroprotective role of erythropoietin in perinatal asphyxia	Dr. Mushtaq Bhat, MD, Sheri Kashmir Srinagar, Jammu & Kashmir, India	Phase II/III	Randomized placebo controlled	NCT02002039	rEpo	500u/kg i.v. every other day for 5 doses	Death or disability at 12- 18 months of life
Perinatal asphyxia	Darbepoetin in newborns undergoing cooling for encephalopathy (DANCE)	Dr. Mariana Baserga MD, University of Utah, Salt Lake City, UT, USA	Phase I/II	Randomized placebo controlled	NCT01471015	Darbe	2 or 10mcg/kg dose i.v. 1st dose before 12hrs, 2nd dose at 7 days	Safety and pharmacokinetics
Perinatal asphyxia	Neonatal erythropoietin and therapeutic hypothermia outcomes in newborn brain injury (NEAT O)	Dr. Yvonne Wu MD MPH, University of San Francisco, San Francisco, CA, USA	Phase I/II	Randomized placebo controlled	NCT01913340	rEpo	1000u/kg i.v. every 48hrs for total 5 doses	Safety and efficacy with neurodevelopmental outcomes at 1 year
Perinatal asphyxia	Erythropoietin to improve survival and neurological outcome in hypoxic ischemic encephalopathy (NEUREPO)	Dr. Juliana Patkai MD PhD, Assistance Publique- HopAitaux de Paris, Paris, France	Phase III	Randomized placebo controlled trial	NCT01732146	rEpo	1000-1500u/kg i.v. 1st dose at <12hrs, 2^nd and 3^rd dose every 24hrs	Survival without neurologic sequelae at 24months
Preterm infants with intraventri- cular hemorrhage	Erythropoietin for repair of cerebral injury in very preterm infants (EpoRepair)	Dr. Sven Wellmann MD, University of Zurich, Zurich, Switzerland	Phase III	Randomized placebo controlled	NCT02076373	rEpo	2000u/kg i.v. 1^st dose at 5 days, 2^nd and 3^rd dose every 24hrs; 4^th dose at 10 days after start; 5^th dose at 17 days	Neurodevelopmental outcome at 5yrs
Infants ≤ 32 weeks gestation	Erythropoietin for neuroprotection in very preterm Infants	Dr. Bai-Horng Su MD PhD, China Medical University Hospital, Taichung, Taiwan	Phase I/II	Randomized placebo controlled	NCT00910234	rEpo	100u/kg or 3000u/kg/dose i.v. 1^st dose at 3-6hrs after birth, 2^nd and 3^rd dose every 24hrs for total 3 dose	Brain injury (intraventricular hemorrhage) and periventricular leukomalacia at 2 months
Premature infants 24-27 weeks gestation	Preterm Epo neuroprotection (PENUT)	Dr. Sandra E Juul MD PhD, University of Washington, Seattle, WA, USA	Phase III	Randomized placebo controlled double blind	NCT01378273	rEpo	1000u/kg i.v. every 48hrs for 6 doses, then 400u/kg s.c three times a week until 32 ^6/7 corrected age	Neurodevelopmental outcome at 24-26 months corrected age by Bayley III
Premature infants 26– 32 weeks gestation	Does erythropoietin improve out come in very preterm infants?	Prof. Hans Ulrich Bucher, MD PhD, Swiss Neonatal Network, Switzerland	Phase II	Randomized parallel assigned	NCT00413946	rEpo	3000u/kg given i.v. at 3hrs, 12-18hrs and 36- 42hrs total 3 doses	Mental development index Bayley II at 24 month corrected age
Premature infants < 32wk gestation	Effect of erythropoietin on preterm brain injury (EPO)	Dr. Huiqing Sun, Ass Prof, Zhengzhou Children’s Hospital, Zhengzhou, China	Phase IV	Prospective parallel assignment	NCT02036073	rEpo	500u/kg every other day for 14 days, beginning < 24 hours of age	Incidence of mental development index <70 at 18 month corrected age

i.v. = intravenous, s.c.= subcutaneous, Darbe = darbepoietin, rEpo = recombinant erythropoietin