California Transport Cooling Trial
Completed · Not applicable
Conditions studied: Hypoxic Ischemic Encephalopathy
In brief
Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single most promising intervention for HIE. Reduction of brain temperature by 2° to 5°C has shown to be neuroprotective in newborn and adult animal models of brain ischemia. Therapeutic hypothermia instituted within 6 hours of birth has been shown to significantly improve survival and neurodevelopmental outcome in term newborns with HIE. Hypothermia is most effective if begun during the latent period, before the secondary energy failure. It is not known whether cooling initiated after 6 hours of age is effective. The goal of this proposal is to test the efficacy of the cooling device in achieving the target temperatures in patients with moderate to severe HIE during transport when compared with current practices.
Key facts
- Study ID
- NCT01683383
- Run by
- Stanford University
- People needed
- 101
- Starts
- 2012-09-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2014-12-08
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Term or near-term infants with gestational age ≥35 weeks who meet institutional criteria for use of therapeutic hypothermia and in whom the decision has been made to perform cooling during transport.
You may not qualify if…
- Presence of a congenital or lethal chromosomal anomaly
- Decision to not provide full intensive care
- Refusal to consent
Where it is running
- Loma Linda University Children's Hospital — Loma Linda, California, United States
- Children's Hospital Central California — Madera, California, United States
- Children's Hospital & Research Center — Oakland, California, United States
- Kaiser Permanente Oakland/Walnut Creek — Oakland, California, United States
- Stanford University — Palo Alto, California, United States
- Sutter Medical Center — Sacramento, California, United States
- Rady Childrens Hospital — San Diego, California, United States
- University of California San Francisco Medical Center — San Francisco, California, United States
- Santa Clara Valley Medical Center — San Jose, California, United States
Full record on ClinicalTrials.gov
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