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.
Drug: erythropoietin Beta
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Full eligibility criteria for NCT01732146
Ages eligible for Study
up to 12 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
Haemorrhagic syndrome unchecked
Head trauma with or without skull fracture
All locations for NCT01732146
Paris, France, 75014
View full eligibility
Tris trial is registered with FDA with number: NCT01732146. The sponsor of the trial is Assistance Publique - Hôpitaux de Paris and it is looking for 120 volunteers for the current phase.
Official trial title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn
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