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

• Status: Completed
• Trial end date: 2017-02-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Epoetin Alfa

Criteria

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