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

Phase 3

Completed

• Conditions: Hypoxic Ischemic Encephalopathy
• Interventions: Drug: erythropoietin Beta; Drug: Placebo

• Registration Number: NCT01732146
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-22
• Study Start: 2013-03-28
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin beta	erythropoietin Beta	1000 to 1500 U/kg/dose X 3 every 24 hours
Placebo	Placebo	0.2 ml saline solution X 3 given every 24 hours

Primary Outcome Measures

Name	Time	Method
Survival without neurologic sequelae	at 24 months

Secondary Outcome Measures

Name	Time	Method
Aspect of brain lesions on MRI	at day 6 and day 12 after birth	Brain MRI performed between day 6 and day 12 after birth
Tolerance of treatment	at 24 months
Mortality rates	Within 24 months	number of dead patients
Rate of moderate and severe sequelae	at 24 months	Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France