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

This study is not yet open for participant recruitment.

Verified November 2012 by Assistance Publique - Hôpitaux de Paris

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01732146

First received: November 19, 2012

Last updated: NA

Last verified: November 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 19, 2012

Last Updated Date

November 19, 2012

Start Date ^ICMJE

December 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival without neurologic sequelea [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Mortality rates [ Time Frame: Within 24 months ] [ Designated as safety issue: Yes ]
Rate of moderate and severe sequelae [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
Mental Developemental index (Brunet Lezine Test), motor, visual and hearing impairment
Aspect of brain lesions on MRI [ Time Frame: at day 6 and day 12 after birth ] [ Designated as safety issue: No ]
Brain MRI performed between day 6 and day 12 after birth
Tolerance of treatment [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelea in Term Newborn

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hypoxic Ischemic Encephalopathy

Intervention ^ICMJE

Drug: Erythropoietin Beta
Erythopoietin 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
Drug: Placebo
Other Name: 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery

Study Arm (s)

Active Comparator: Erythropoietin beta
1000 to 1500 U/kg/dose X 3 every 24 hours

Intervention: Drug: Erythropoietin Beta
Placebo Comparator: Placebo
0.2 ml saline solution X 3 given every 24 hours

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

330

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Term or near-term newborn (> = 36 weeks agestational age)
Moderate to severe encephalopathy
undergoing moderate controlled hypothermia started within 6 hours after delivery
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

Gender

Both

Ages

up to 12 Hours

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Juliana Patkai, MD, PhD	+ 33 1 58 41 54 12	juliana.patkai@cch.aphp.fr
Contact: Laurence Lecomte, PhD	: +33 1 71 19 64 94	laurence.lecomte@nck.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01732146

Other Study ID Numbers ^ICMJE

110111

Has Data Monitoring Committee

Yes

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Juliana Patkai, MD, PhD

Cochin Hospital

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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