Status:
COMPLETED
Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy
Lead Sponsor:
Zhengzhou University
Collaborating Sponsors:
Zhengzhou Children's Hospital, China
Medical University Innsbruck
Conditions:
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
1-48 years
Phase:
PHASE1
PHASE2
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 neuropro...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00808704
Start Date
August 1 2003
End Date
July 1 2008
Last Update
December 16 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052