California Transport Cooling Trial
Public ClinicalTrials.gov record NCT01683383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Randomized Clinical Trial of Therapeutic Hypothermia During Transport for Hypoxic Ischemic Encephalopathy (HIE): Device-regulated Cooling Versus Standard Practice.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01683383
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- Up to 6 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2012 (Type not available)
- Primary completion
- Oct 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Dec 8, 2014
2012 – 2013
United States locations
- U.S. sites
- 9
- U.S. states
- 1
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Children's Hospital | Loma Linda | California | 92354 | — |
| Children's Hospital Central California | Madera | California | 93636 | — |
| Children's Hospital & Research Center | Oakland | California | 94609 | — |
| Kaiser Permanente Oakland/Walnut Creek | Oakland | California | 94611 | — |
| Stanford University | Palo Alto | California | 94305 | — |
| Sutter Medical Center | Sacramento | California | 95819 | — |
| Rady Childrens Hospital | San Diego | California | 92123 | — |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | — |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01683383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2014 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01683383 live on ClinicalTrials.gov.