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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
  Purpose

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.


Condition Intervention Phase
Hypoxic Ischemic Encephalopathy
 Drug: Erythropoietin Beta
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelea in Term Newborn

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 330
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Erythropoietin beta
1000 to 1500 U/kg/dose X 3 every 24 hours
 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
Placebo Comparator: Placebo
0.2 ml saline solution X 3 given every 24 hours
 Drug: Placebo
Other Name: 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery

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.

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732146

Contacts
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

Locations
France
Cochin Hospital Not yet recruiting
Paris, France, 75014
Contact: Juliana Patkai, PhD     + 33 1 58 41 54 12     Juliana.patkai@cch.aphp.fr    
Sub-Investigator: Juliana Patkai, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Juliana Patkai, MD, PhD Cochin Hospital
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01732146     History of Changes
Other Study ID Numbers: 110111
Study First Received: November 19, 2012
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hypoxic Ischemic Encephalopathy
Term neonate
Neuroprotection
Erythropoeitin

Additional relevant MeSH terms:
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
 Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013