Education and Training
California Transport Cooling Trial
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- device: Device (servo-regulated cooling)
- other: Control (standard practice)
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of a congenital or lethal chromosomal anomaly
- Decision to not provide full intensive care
- Refusal to consent
Ages Eligible for Study
N/A - 6 Hours
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa Van Meurs, M.D.
650-723-5711
Not Recruiting