Status:
UNKNOWN
Whole Body Cooling Using Phase Changing Material
Lead Sponsor:
Robertson, Nicola, M.D.
Collaborating Sponsors:
Thayyil, Sudhin
Conditions:
Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
PHASE2
Brief Summary
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy. Effectivene...
Detailed Description
Meta-analyses of these trials show that therapeutic hypothermia increases survival with normal neurological function (pooled risk ratio of 1.53) with a number needed to treat of 8 (95% confidence inte...
Eligibility Criteria
Inclusion
- Apgar score of \<5 at 5 minutes or continued resuscitation at 5 minutes
- Neonatal encephalopathy
Exclusion
- Imminent death
- Major congenital malformations
- Gestation \<36 weeks
- Birthweight less than 1.8 kg
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01138176
Start Date
July 1 2009
End Date
August 1 2011
Last Update
June 7 2010
Active Locations (1)
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1
Calicut Medical College
Calicut, India