N/A
N=101
California Transport Cooling Trial
Hypoxic Ischemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT01683383 ↗Enrolled (actual)
101
Serious AEs
16.0%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Temperatures in Target Range During Transport — 0; 73 Percentage of temperatures — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device (servo-regulated cooling) (Device); Control (standard practice) (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Temperatures in Target Range During Transport |
0; 73 | <0.001 sig |
| SECONDARY Time to Target Temperature |
63; 44 | 0.04 sig |
| SECONDARY Percentage of Participants in the Target Range at 1 Hour |
8; 28 | — |
| SECONDARY Participants in Target Temperature Range Anytime During Transport |
24; 41 | <0.001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01683383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.