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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01732146
Other study ID # P110111
Secondary ID 2012-001417-17
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT01471015 - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy Phase 1/Phase 2
Completed NCT01649648 - Autologous Cord Blood Cells for Brain Injury in Term Newborns Phase 1
Completed NCT01481207 - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
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Completed NCT00945789 - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE) Phase 1/Phase 2
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Withdrawn NCT01128673 - MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE) N/A
Completed NCT02349672 - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
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Active, not recruiting NCT01138176 - Whole Body Cooling Using Phase Changing Material Phase 1/Phase 2
Recruiting NCT02578823 - Targeted Temperature Management After In-Hospital Cardiac Arrest N/A
Terminated NCT01765218 - Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy Phase 1/Phase 2
Completed NCT01241019 - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia Phase 2
Completed NCT00620711 - Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy Phase 1