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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae 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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

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

Original Primary Outcome: Survival without neurologic sequelea [ Time Frame: at 24 months ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Mortality rates [ Time Frame: Within 24 months ]
  • Rate of moderate and severe sequelae [ Time Frame: at 24 months ]
    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 ]
    Brain MRI performed between day 6 and day 12 after birth
  • Tolerance of treatment [ Time Frame: at 24 months ]


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: November 19, 2012
Date Started: March 2013
Date Completion: December 2017
Last Updated: August 18, 2015
Last Verified: August 2015