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NCT01683383 · ClinicalTrials.gov registry record · NA
California Transport Cooling Trial
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
NCT01683383: Completed NA study, sponsored by Stanford University.
NCT01683383 is a NA study that has completed, run by Stanford University. The registered enrollment target is 101 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683383, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.
Interventions
- DEVICE Device (servo-regulated cooling)
- OTHER Control (standard practice)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT01683383 record still lists
NCT01683383 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Device (servo-regulated cooling) is the first listed.
NCT01683383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683383 about?
NCT01683383 is a clinical study titled "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 ne...
What is the current status of trial NCT01683383?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2012-09. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01683383?
The interventions under investigation include: Device (servo-regulated cooling) (DEVICE), Control (standard practice) (OTHER).
Who is sponsoring clinical trial NCT01683383?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683383's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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