NCT00808704

Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

Effect of Erythropoietin on Neonatal Hypoxic Ischemic Encephalopathy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Zhengzhou University · Academic / Other
• Sex: All
• Age: 1 Hour – 48 Hours
• Healthy volunteers: Not accepted

Summary

Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally. Although many neuroprotective strategies appeared promising in animal models, most of them have failed clinically. Erythropoietin (EPO) is an endogenous cytokine originally identified for its role in erythropoiesis. Clinical trial has demonstrated the safety and efficacy of recombinant human erythropoietin (r-hu-EPO) in the prevention or treatment of anemia of prematurity. To date, there are no reports evaluating possible effects of EPO on neonatal HIE.

Detailed description

Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions.Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. Systemically administered EPO was neuroprotective in neonatal brain injury models. Clinical study on adult stroke showed improved outcome. However, treating HIE with EPO raises a series of questions such as: i) Can the patient population of this study readily be compared with those in the hypothermia trials? ii) What are the pharmacokinetics of EPO, including issues of dosage and timing, and does administered EPO cross the blood-brain-barrier? iii) How does the effectiveness, side effects and potentials of EPO therapy compare with induced hypothermia?

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DRUG	recombinant human erythropoietin	r-hu-EPO were administered either 300 U/kg or 500 U/kg, subcutaneously the first time and then intravenously every other day for 2 weeks.

Timeline

• Start date: 2003-08-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-12-16
• Last updated: 2008-12-16

Locations

1 site across 1 country: China