NCT00795119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 3, 2009

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

November 19, 2008

Last Update Submit

April 2, 2009

Conditions

Intracranial Hemorrhage

Keywords

Near Infrared SpectroscopyDiagnosisChildren

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of NIRS

    Study conclusion

Secondary Outcomes (1)

  • specificity of NIRS, positive/negative predictive value

    Study conclusion

Study Arms (1)

NIRS

EXPERIMENTAL

Children who undergo NIRS

Device: Near Infrared Spectroscopy (NIRS)

Interventions

Near Infrared Spectroscopy (NIRS)DEVICE

NIRS of the head is undertaken at the time of CT or MRI examination

NIRS

Eligibility Criteria

AgeUp to 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K-6R9, Canada

Location

MeSH Terms

Conditions

Intracranial HemorrhagesDisease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Steven Bellemare, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 21, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 3, 2009

Record last verified: 2008-11

Locations

CA(1)