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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732146
First Posted: November 22, 2012
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Survival without neurologic sequelae [ Time Frame: at 24 months ]

Secondary Outcome Measures:
  • Mortality rates [ Time Frame: Within 24 months ]
    number of dead patients

  • Rate of moderate and severe sequelae [ Time Frame: at 24 months ]
    Mental Developmental 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 ]
    Brain MRI performed between day 6 and day 12 after birth

  • Tolerance of treatment [ Time Frame: at 24 months ]

Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (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
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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732146


Locations
France
Cochin Hospital
Paris, France, 75014
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
First Submitted: November 19, 2012
First Posted: November 22, 2012
Last Update Posted: August 19, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Epoetin Alfa
Hematinics