A Phase 3 interventional study of erythropoietin Beta and Placebo in Hypoxic Ischemic Encephalopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 12 Hours. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.
Hypoxic-ischemic encephalopathy remains the main cause of death or long term neurologic impairments in neonates. Yet, therapies for birth asphyxia are currently limited. Hypothermia when applied within 6 hours after birth demonstrate partial improvement in outcome of newborns specially those with moderate form. Erythropoietin and its receptors are upregulated after brain injury in ischemic conditions. Systemically administered erythropoietin is neuroprotective in animal models of birth asphyxia. To date, one study demonstrate improvement neurologic outcome in asphyxiated term newborn under erythropoietin treatment but no reports evaluating beneficial of erythropoietin associated with cooling. This is a large randomised controlled trial to evaluate the efficacy of high dose erythropoietin on outcome at two years of asphyxiated term newborns undergoing cooling.
234 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 83 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 135 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1000 to 1500 U/kg/dose X 3 every 24 hours
Drug: erythropoietin Beta
0.2 ml saline solution X 3 given every 24 hours
Drug: Placebo
erythropoietin intravenous injection (5000 U/ 0.3 ml)1000 to 1500 U/kg/dose X 3 given every 24 hours with the first dose within 12 hours of delivery
Also known as: 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery
Survival without neurologic sequelae
Time frame: at 24 months
Mortality rates
number of dead patients
Time frame: Within 24 months
Rate of moderate and severe sequelae
Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment
Time frame: at 24 months
Aspect of brain lesions on MRI
Brain MRI performed between day 6 and day 12 after birth
Time frame: at day 6 and day 12 after birth
Tolerance of treatment
Time frame: at 24 months
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris