A Trial to Determine the Efficacy of Near Infrared Spectr... | NCT00795119

Studies
A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children

NCT00795119

Sponsor

IWK Health Centre

Status

Completed

Last Update Posted

Apr 3, 2009Estimated

Enrollment

73Actual

Phase

Not Applicable

Conditions

Intracranial Hemorrhage

Interventions

Near Infrared Spectroscopy (NIRS)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Nov 19, 2008

First Posted Date

Nov 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2009

Last Update Posted Date

Apr 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIRS	Experimental	Children who undergo NIRS	Device: Near Infrared Spectroscopy (NIRS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Near Infrared Spectroscopy (NIRS)	Device	NIRS of the head is undertaken at the time of CT or MRI examination	NIRS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of NIRS		Study conclusion

Secondary Outcomes

Measure	Description	Time Frame
specificity of NIRS, positive/negative predictive value		Study conclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children under 3 years of age who undergo a CT of the head or MRI of the head.

Exclusion Criteria:

Lack of parental consent
Neurosurgical intervention between CT/MRI and NIRS scanning.
Scalp hematoma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven Bellemare, MD	IWK Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IWK Health Centre		Halifax	Nova Scotia	B3K-6R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020300	Intracranial Hemorrhages
D004194	Disease

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013057	Spectrum Analysis

Browse Leaves

Not provided

Browse Branches

Not provided