Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222742
Status:
TERMINATED
Last Update Posted:
2012-07-11
First Post:
2005-09-16
Brief Title:
Hypothermia in Children After Trauma
Sponsor:
Phoenix Childrens Hospital
Organization:
Phoenix Childrens Hospital
Study Overview
Official Title:
Pediatric Traumatic Brain Injury Consortium Hypothermia
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The primary specific aim of this RCT is to determine the effect of induced moderate HYPO 32-33 C after severe TBI in children on mortality at 3 months post injury The primary outcome measure will be the GOS the primary time point for evaluation is 3 months Further secondary functional outcome measures will include the GOS - Extended Pediatrics GOS - E Peds and Vineland Adaptive Behavior Scale VABS and will be assessed in conjunction with the GOS at 6 and 12 months post injury
The secondary hypotheses are based on the results and analysis of the Pilot Clinical Trial completed and recently published Adelson et al NEUROSURGERY 56 4 740-754 2005 These secondary hypotheses include that induced moderate hypothermia HYPO 32-33 C after severe TBI in children and maintained for 48 h
will improve other outcome assessments including neurocognitive status on performance-based neuropsychological testing across the domains of intellectual development learning and memory language motor and psychomotor skills visuo-spatial abilities attention and executive function and behavior at only 6 and 12 months after injury
HYPO will improve long term outcome of all age ranges and across genders in infants young preadolescent and adolescent children AND
HYPO will lessen intracranial hypertension and lessen the intensity of therapy necessary for control of ICP
Based on these hypotheses further secondary specific aims are proposed
Specific Aim 2 To determine the effect of early induced moderate HYPO 32-33C after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability development memory and learning and behavior at 6 and 12 months post injury
Specific Aim 3 To determine the effect of early induced moderate HYPO after severe TBI in children of different age ranges 6 y and 6- 16 y on mortality and 6 and 12 months functional and neurocognitive outcomes
Specific Aim 4 To determine the effect of early moderate HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure CPP
The secondary hypotheses are based on the results and analysis of the Pilot Clinical Trial completed and recently published Adelson et al NEUROSURGERY 56 4 740-754 2005 These secondary hypotheses include that induced moderate hypothermia HYPO 32-33 C after severe TBI in children and maintained for 48 h
will improve other outcome assessments including neurocognitive status on performance-based neuropsychological testing across the domains of intellectual development learning and memory language motor and psychomotor skills visuo-spatial abilities attention and executive function and behavior at only 6 and 12 months after injury
HYPO will improve long term outcome of all age ranges and across genders in infants young preadolescent and adolescent children AND
HYPO will lessen intracranial hypertension and lessen the intensity of therapy necessary for control of ICP
Based on these hypotheses further secondary specific aims are proposed
Specific Aim 2 To determine the effect of early induced moderate HYPO 32-33C after severe TBI in children on global function and neurocognitive outcomes in the areas of intellectual ability development memory and learning and behavior at 6 and 12 months post injury
Specific Aim 3 To determine the effect of early induced moderate HYPO after severe TBI in children of different age ranges 6 y and 6- 16 y on mortality and 6 and 12 months functional and neurocognitive outcomes
Specific Aim 4 To determine the effect of early moderate HYPO after severe TBI in children on reducing intracranial hypertension and maintaining adequate cerebral perfusion pressure CPP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NS052478-01 | None | None | None |