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Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

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ClinicalTrials.gov Identifier: NCT00808704
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : December 16, 2008
Sponsor:
Collaborators:
Zhengzhou Children's Hospital, China
Medical University Innsbruck
Göteborg University
Information provided by:
Zhengzhou University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Drug: recombinant human erythropoietin Phase 1 Phase 2

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?


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Erythropoietin on Neonatal Hypoxic Ischemic Encephalopathy
Study Start Date : August 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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.
    Other Name: EPO


Primary Outcome Measures :
  1. Mortality and disability rate. Mortality and disability rate at 18months of age. [ Time Frame: 18 months ]


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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Apgar score of 5 or less at 5 min after birth or continued need for resuscitation, including endotracheal or mask ventilation at 10 min after birth.
  • The severity of encephalopathy, moderate or severe, was assessed by certified examiners according to the criteria of Sarnat and Sarnat(13), consisting of altered state of consciousness: lethargy, stupor or coma, and at least one or more of hypotonia, abnormal reflexes including oculomotor or pupillary abnormalities, absent or weak sucking or clinical seizures.

Exclusion Criteria:

  • Major congenital abnormalities, head trauma or skull fracture causing major intracranial hemorrhage, mild HIE, financial problems of the parents, lack of permanent address or postnatal age > 48 hrs

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808704


Locations
China, Henan
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Zhengzhou Children's Hospital, China
Medical University Innsbruck
Göteborg University
Investigators
Study Director: Changlian Zhu, MD, PhD Zhengzhou University

Responsible Party: Professor Xiaoyang Wang, Zhengzhou University
ClinicalTrials.gov Identifier: NCT00808704     History of Changes
Other Study ID Numbers: HN-200312
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: December 16, 2008
Last Verified: December 2008

Keywords provided by Zhengzhou University:
asphyxia
erythropoietin
neonates

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Epoetin Alfa
Hematinics