Status:
COMPLETED
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Qingdao Children's Hospital
Guangxi Maternity and Infant health Hospital
Conditions:
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
Detailed Description
Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of mild hypothermia to both the mature ...
Eligibility Criteria
Inclusion
- Age up to 6 hours
- Gestational age ≥ 36 weeks and birth weight ≥ 2500 g
- Apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas pH \< 7.0 or base deficit ≤ 16 mmol/L, and/or need for resuscitation or ventilation at 5 minutes of age
- Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc)
Exclusion
- Major congenital abnormalities
- Infection
- Other etiology of induced brain injury
- Severe anemia (Hb \< 120 g/L)
- Eligible infants assessed for the severity of HIE according to criteria of the Neonatal Association of Chinese Academy of Pediatrics 25 modified from Sarnat and Sarnat 26 in 1986
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00890409
Start Date
May 1 2002
End Date
August 1 2005
Last Update
May 28 2009
Active Locations (1)
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1
Children's Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201102