Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683383
The ClinicalTrials.gov registry entry for NCT01683383 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Device (servo-regulated cooling) is the first listed.
NCT01683383 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.