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

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoxic Ischemic Encephalopathy

Intervention: erythropoietin Beta (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Juliana Patkai, MD, PhD, Principal Investigator, Affiliation: Cochin Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Survival without neurologic sequelae

Secondary outcome:

Mortality rates

Rate of moderate and severe sequelae

Aspect of brain lesions on MRI

Tolerance of treatment

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

Minimum age: N/A. Maximum age: 12 Hours. Gender(s): Both.

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

Locations and Contacts

Cochin Hospital, Paris 75014, France
Additional Information

Related publications:

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.

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.

Starting date: March 2013
Last updated: August 18, 2015

Page last updated: August 20, 2015

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