CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
Device (servo-regulated cooling) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01683383
NCT01683383N/ACompleted

A Randomized Clinical Trial of Therapeutic Hypothermia During Transport for Hypoxic Ischemic Encephalopathy (HIE): Device-regulated Cooling Versus Standard Practice.

Stanford University·interventional·Posted Sep 11, 2012·Updated Dec 8, 2014

In Brief

A clinical study evaluating Device (servo-regulated cooling) and Control (standard practice) for Hypoxic Ischemic Encephalopathy. Completed, enrolled 101 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2012
Enrollment StartSep 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.8 years ago

Interventions

Device (servo-regulated cooling)device

Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.

Control (standard practice)other

Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.