CompletedNot Applicable

Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

China70 participantsStarted 2014-01

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of Cooling

Timeframe: 4 hours

Body Temperature Fluctuations in Maintenance Phase

Timeframe: 12 hours

Rate of Rewarming

Timeframe: 24 to 48 hours

Trial details

NCT IDNCT02544542

SponsorChildren's Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

View on ClinicalTrials.gov More Hypoxic-Ischemic Encephalopathy trials