Status:
COMPLETED
Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)
Lead Sponsor:
Tanta University
Conditions:
Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
PHASE2
Brief Summary
In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.
Detailed Description
During HIE free radicals are generated within mitochondria and also as byproducts in the synthesis of prostaglandins.These free radicals ignite a secondary phase of subsequent damage to the brain by a...
Eligibility Criteria
Inclusion
- Inborn infants at term gestation (38-42 weeks)
- Apgar score ≤ 3 at 5 minutes and/or delayed first breath beyond five minutes after birth
- Profound metabolic or mixed acidosis with serum bicarbonate \<12 mMol/L in initial arterial blood gas
- Evidence of encephalopathy such as stupor, coma, seizures, or hypotonia in the immediate neonatal period
Exclusion
- Twin gestation
- Maternal diabetes
- Congenital malformations of the central nervous system
- Chromosomal abnormalities
- Chorioamnionitis and congenital infections
- Intrauterine growth restriction
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00945789
Start Date
October 1 2007
End Date
June 1 2009
Last Update
September 28 2009
Active Locations (1)
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1
Tanta University Faculty of Medicine
Tanta, Egypt