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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-28

Study Completion Date

2017-02-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoxic Ischemic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Erythropoietin beta

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

Group Type ACTIVE_COMPARATOR

erythropoietin Beta

Intervention Type DRUG

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

0.2 ml saline solution X 3 given every 24 hours

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery

Eligibility Criteria

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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

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No