This trial is active, not recruiting.

Condition hypoxic ischemic encephalopathy
Treatments erythropoietin beta, placebo
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date March 2013
End date March 2017
Trial size 120 participants
Trial identifier NCT01732146, 110111


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
1000 to 1500 U/kg/dose X 3 every 24 hours
erythropoietin beta
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
(Placebo Comparator)
0.2 ml saline solution X 3 given every 24 hours
placebo 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery

Primary Outcomes

Survival without neurologic sequelae
time frame: at 24 months

Secondary Outcomes

Mortality rates
time frame: Within 24 months
Rate of moderate and severe sequelae
time frame: at 24 months
Aspect of brain lesions on MRI
time frame: at day 6 and day 12 after birth
Tolerance of treatment
time frame: at 24 months

Eligibility Criteria

Male or female participants up to 12 hours old.

Inclusion Criteria: - Term or near-term newborn (> = 36 weeks gestational age) - Moderate to severe encephalopathy - undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° C + / - 0.5 ° C before H6 - Beneficiary of social security plan - Informed consent parental authority Exclusion Criteria: - Impossibility of getting controlled hypothermia before H6 - Infant older than 12 hours of age - Chromosomal or significant congenital abnormality - Predictable surgery in the first 3 days of life - Uncontrolled collapse - Haemorrhagic syndrome unchecked - Head trauma with or without skull fracture

Additional Information

Official title Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn
Principal investigator Juliana Patkai, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.