Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Epoetin Alfa; Nitric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• Twin gestation

• Maternal diabetes

• Congenital malformations of the central nervous system

• Chromosomal abnormalities

• Chorioamnionitis and congenital infections

• Intrauterine growth restriction