At a glance
ClinicalIndex Comparison RecordN/ACompleted· 70 enrolled
Drug / intervention
Rectum cooling system +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.
A Comparative Clinical Trial of a New Rectum Cooling System Versus Temperature-adjusting Blanket on Patients of Hypoxic-ischemic Brain Damage
Children's Hospital of Chongqing Medical University·interventional·Posted Sep 9, 2015·Updated Feb 2, 2017
In Brief
A clinical study evaluating Rectum cooling system and Hyper-hypothermia blanket for Hypoxic-Ischemic Encephalopathy. Completed, enrolled 70 participants across 1 site.
Detailed Summary
This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoxic-Ischemic Encephalopathy
CountriesChina
CollaboratorsChongqing Science and Technology Commission
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedSep 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedSep 9, 2015
Enrollment StartJan 1, 2014
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago
Interventions
Rectum cooling systemdevice
Hyper-hypothermia blanketdevice