Status:
COMPLETED
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Lead Sponsor:
Zhengzhou University
Collaborating Sponsors:
Medical University Innsbruck
Conditions:
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
1-10 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. Birth asphyxia accounts for 23% of neonatal deaths globally and surviv...
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
- Gestation age ≥37 weeks and body weight \>2500g.
- with one of the following factors:
- Apgar score\<5 at 5min;
- Assisted respiration \>3min due to respiratory distress;
- pH≤7.1 of cord or arterial blood within 60min after birth;
- clinical manifestation of encephalopathy during the first 10 hrs of life.
Exclusion
- Major congenital abnormalities;
- Head trauma or skull fracture causing major intracranial hemorrhage;
- Mild HIE;
- Financial problems of the parents;
- Lack of permanent address;
- Postnatal age \> 10 hrs
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00817401
Start Date
July 1 2002
End Date
June 1 2008
Last Update
January 6 2009
Active Locations (1)
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1
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052