Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage
Hypoxic-Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Mild Hypothermia, Hypoxic-Ischemic Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- Neonatal HIE
- After cardiopulmonary resuscitation (CPR)
- Severe craniocerebral injury (GCS < 8)
- Acute central nervous system infection and severe brain edema or lasting convulsion
- Severe cerebral edema caused by various metabolic factors
Exclusion Criteria:
- End-stage heart failure
- Uncorrected serious cardiovascular dysfunction
- Active intracranial hemorrhage not under control
- Platelet count < 50 * 10^9 / L
Sites / Locations
- Children's Hospital of Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rectum cooling system
Hyper-hypothermia blanket
Insert the self-made device into the patient's rectum, pump ice-cold saline in to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by controlling the pumping speed of saline.
Let the patient sleep on the hyper-hypothermia blanket, set the target temperature to induce mild hypothermia, sustain the desired temperature for 12 hours,then let the body rewarm slowly. Body temperature changes are achieved by adjusting the target temperature of the device accordingly.