Hypoxic Ischemic Encephalopathy Clinical Trial
— NeurepoOfficial title:
Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn
Verified date | April 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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
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 |
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