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Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

2014-08-27 03:25:37 | BioPortfolio

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.

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?

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Hypoxic-Ischemic Encephalopathy

Intervention

recombinant human erythropoietin

Location

NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou
Henan
China
450052

Status

Completed

Source

Zhengzhou University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:37-0400

Clinical Trials [789 Associated Clinical Trials listed on BioPortfolio]

PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns

Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conju...

High-dose Erythropoietin for Asphyxia and Encephalopathy

Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including ...

Neonatal Erythropoietin in Asphyxiated Term Newborns

The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..

Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).

PubMed Articles [13239 Associated PubMed Articles listed on BioPortfolio]

High-Dose Erythropoietin Population Pharmacokinetics in Neonates with Hypoxic-Ischemic Encephalopathy Receiving Hypothermia.

High-dose erythropoietin (Epo) is a promising neuroprotective treatment in neonates with hypoxic ischemic encephalopathy (HIE) receiving hypothermia. We evaluated the pharmacokinetics and dose-exposur...

Distinguishing Arterial Ischemic Stroke From Hypoxic-Ischemic Encephalopathy in the Neonate at Birth.

To identify perinatal risk factors that can distinguish arterial ischemic stroke from hypoxic-ischemic encephalopathy at birth.

Amplitude Integrated Electroencephalogram as a Prognostic Tool in Neonates with Hypoxic-Ischemic Encephalopathy: A Systematic Review.

Perinatal management and prognostic value of clinical evaluation and diagnostic tools have changed with the generalization of therapeutic hypothermia (TH) in infants with hypoxic-ischemic encephalopat...

The Severity of Hypoxic-Ischemic Encephalopathy Correlates With Multiple Organ Dysfunction in the Hypothermia Era.

The objectives are to 1) determine whether there is a positive correlation between the severity of hypoxic-ischemic encephalopathy and multiple organ dysfunction and 2) evaluate the organ dysfunction ...

Vitamin D Insufficiency in Neonatal Hypoxic-Ischemic Encephalopathy.

Vitamin D has neuroprotective and immunomodulatory properties, and deficiency is associated with worse stroke outcomes. Little is known about effects of hypoxia-ischemia or hypothermia treatment on vi...

Medical and Biotech [MESH] Definitions

This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.

Cell surface proteins that bind erythropoietin with high affinity and trigger intracellular changes influencing the behavior of cells.

A nitroimidazole that sensitizes normally radio-resistant hypoxic cells to radiation. It may also be directly cytotoxic to hypoxic cells and has been proposed as an antineoplastic.

ERYTHROPOIETIN prepared by recombinant DNA technology.

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