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

Hypoxic Ischemic Encephalopathy Clinical Trial

— Neurepo  

Official title:

Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732146
• Other study ID #: P110111
• Secondary ID: 2012-001417-17
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2013
• Est. completion date: February 14, 2017

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia

Intervention

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

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without neurologic sequelae		at 24 months
Secondary	Mortality rates	number of dead patients	Within 24 months
Secondary	Rate of moderate and severe sequelae	Mental Developmental index (Brunet Lezine Test), motor, visual and hearing impairment	at 24 months
Secondary	Aspect of brain lesions on MRI	Brain MRI performed between day 6 and day 12 after birth	at day 6 and day 12 after birth
Secondary	Tolerance of treatment		at 24 months