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

NCT02544542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-02-02

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

DEVICE

Rectum cooling system

DEVICE

Hyper-hypothermia blanket

Sponsors & Collaborators

  • Chongqing Science and Technology Commission

    collaborator OTHER

  • Children's Hospital of Chongqing Medical University

    lead OTHER

Principal Investigators

  • Zelan Zuo, Bachelor · Children's Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544542 on ClinicalTrials.gov