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Hypothermia in Children After Trauma

NCT00222742 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2012-07-11

No results posted yet for this study

Summary

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain injury (TBI) in children and maintained for 48 hours will improve mortality at 3 months and 12 month functional outcome as assessed by the Glasgow Outcome Scale (GOS).

Conditions

Interventions

PROCEDURE

induced moderate hypothermia

Subjects assigned to the treatment arm will be cooled to 32-33 °C for 48 hours and then slowly warmed.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • P. David Adelson, MD · Phoenix Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-05-31
Completion
2012-03-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00222742 on ClinicalTrials.gov