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Hypothermia in Traumatic Brain Injury in Children (HiTBIC)

NCT00282269 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-06-22

No results posted yet for this study

Summary

The purpose of this study is:

* To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in children with severe traumatic brain injury (TBI).
* To determine whether in children with severe traumatic brain injury, prolonged initial hypothermia (minimum 72 hours at 32-33 degrees) improves the proportion of good outcomes 12 months after injury when compared to initial normothermia (36-37 degrees).

Conditions

Interventions

PROCEDURE

Induced Hypothermia

Induced Hypothermia within 6 hours of injury and maintained for a minimum of 72 hours

Sponsors & Collaborators

  • Australia and New Zealand Intensive Care Society

    lead OTHER

Principal Investigators

  • John Beca, FJFICM · Starship Children's Hospital, Auckland, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Australia
  • New Zealand

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 NCT00282269 on ClinicalTrials.gov