Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

NCT00808704 | Completed Phase 1 DMC

• 1 other identifier: HN-200312
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

asphyxia; erythropoietin; neonates

Outcome Measures

Primary Outcomes (1)

• Mortality and disability rate. Mortality and disability rate at 18months of age.

  18 months

Interventions

recombinant human erythropoietin DRUG

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.

Also known as: EPO

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhengzhou University: lead
• Zhengzhou Children's Hospital, China: collaborator
• Medical University Innsbruck: collaborator
• Göteborg University: collaborator

Study Sites (1)

NICU, the Third Affiliated Hospital, Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Death; Pathologic Processes; Wounds and Injuries

Study Officials

• Changlian Zhu, MD, PhD

  Zhengzhou University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: August 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 16, 2008

Record last verified: 2008-12

Locations

CN (1)