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Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

2014-08-26 22:25:37 | 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: 2014-08-26T22:25:37-0400

Clinical Trials [603 Associated Clinical Trials listed on BioPortfolio]

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.

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).

Late Hypothermia for Hypoxic-Ischemic Encephalopathy

This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ...

Study of Cerebrolysin for Treatment of Neonatal Hypoxic Ischemic Encephalopathy

The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic en...

A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-isch...

PubMed Articles [12828 Associated PubMed Articles listed on BioPortfolio]

Grading hypoxic-ischemic encephalopathy severity in neonatal EEG using GMM supervectors and the support vector machine.

This work presents a novel automated system to classify the severity of hypoxic-ischemic encephalopathy (HIE) in neonates using EEG.

Serum calcium concentrations and incidence of hypocalcemia in infants with moderate or severe hypoxic-ischemic encephalopathy: Effect of therapeutic hypothermia.

Hypocalcemia is a common morbidity in asphyxiated infants. Therapeutic hypothermia (TH), the standard of care for infants with moderate and severe hypoxic-ischemic encephalopathy (HIE), promotes neuro...

Intestinal ultrasonography in infants with moderate or severe hypoxic-ischemic encephalopathy receiving hypothermia.

Infants with hypoxic-ischemic encephalopathy (HIE) may develop multiorgan dysfunction, but assessment of intestinal involvement is imprecise and based on nonspecific clinical signs that may occur seve...

Serum Lactate, Brian Magnetic Resonance Imaging and Outcome of Neonatal Hypoxic Ischemic Encephalopathy after Therapeutic Hypothermia.

Serum lactate was used to predict the severity and outcome of neonatal hypoxic ischemic encephalopathy (HIE) before the era of therapeutic hypothermia (TH). There is no report on neurodevelopment (ND)...

Association of Brain Injury and Neonatal Cytokine Response during Therapeutic Hypothermia (TH) in Newborns with Hypoxic-Ischemic Encephalopathy (HIE).

Cytokines have been proposed as mediators of neonatal brain injury via neuroinflammatory pathways triggered by hypoxia-ischemia. Limited data are available on cytokine profiles in larger cohorts of ne...

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.

A clinically diverse group of epilepsy syndromes characterized either by myoclonic seizures or by myoclonus in association with other seizure types. Myoclonic epilepsy syndromes are divided into three subtypes based on etiology: familial, cryptogenic, and symptomatic (i.e., occurring secondary to known disease processes such as infections, hypoxic-ischemic injuries, trauma, etc.).

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