Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy (Neurepo)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Hypoxic Ischemic Encephalopathy

Treatments: Drug: erythropoietin Beta; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01732146

P110111

2012-001417-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Erythropoietin beta

Active Comparator group

Description:

1000 to 1500 U/kg/dose X 3 every 24 hours

Treatment:

Drug: erythropoietin Beta

Placebo

Placebo Comparator group

Description:

0.2 ml saline solution X 3 given every 24 hours

Treatment:

Drug: Placebo