Clinical trial NCT01732146: Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
Official title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Hypoxic Ischemic Encephalopathy
Term neonate
Neuroprotection
erythropoietin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 120
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Survival without neurologic sequelae
timeFrame: at 24 months
Secondary outcomes:
measure: Mortality rates
timeFrame: Within 24 months
measure: Rate of moderate and severe sequelae
timeFrame: at 24 months
measure: Aspect of brain lesions on MRI
timeFrame: at day 6 and day 12 after birth
measure: Tolerance of treatment
timeFrame: at 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Cochin Hospital
name: Juliana Patkai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1542/peds.2008-3553. Epub 2009 Jul 27.
citation: Goodarzi MO, Carmina E, Azziz R. DHEA, DHEAS and PCOS. J Steroid Biochem Mol Biol. 2015 Jan;145:213-25. doi: 10.1016/j.jsbmb.2014.06.003. Epub 2014 Jul 5.