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

This study is currently recruiting participants.
Verified July 2013 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: August 2, 2013
Last verified: July 2013

November 19, 2012
August 2, 2013
March 2013
March 2017   (final data collection date for primary outcome measure)
Survival without neurologic sequelea [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01732146 on ClinicalTrials.gov Archive Site
  • Mortality rates [ Time Frame: Within 24 months ] [ Designated as safety issue: Yes ]
    number of dead patients
  • Rate of moderate and severe sequelae [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    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 ] [ 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelea in Term Newborn

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypoxic Ischemic Encephalopathy
  • 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
  • Drug: Placebo
    Other Name: 0.2 ml saline solution X 3 given every 24 hours with the first dose within 12 hours of delivery
  • 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
Zhu C, Kang W, Xu F, Cheng X, Zhang Z, Jia L, Ji L, Guo X, Xiong H, Simbruner G, Blomgren K, Wang X. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy. Pediatrics. 2009 Aug;124(2):e218-26. Epub 2009 Jul 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
December 2017
March 2017   (final data collection date for primary outcome measure)

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
  • 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
Both
up to 12 Hours
No
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
France
 
NCT01732146
110111
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Juliana Patkai, MD, PhD Cochin Hospital
Assistance Publique - Hôpitaux de Paris
July 2013

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