NCT01483703

Brief Summary

The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

November 29, 2011

Last Update Submit

October 28, 2022

Conditions

Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

  • Medical tool

    Laser Speckle Imaging device to image superficial cerebral blood flow in the infant's head

    up to 12 months

Study Arms (1)

Diagnostic tool

Laser Speckle Imaging of Critical Care Neonates

Device: Laser Speckle Imaging

Interventions

Laser Speckle ImagingDEVICE

Laser Speckle Imaging of Critical Care Neonates

Diagnostic tool

Eligibility Criteria

Age1 Minute - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children

You may qualify if:

  • New born or infant

You may not qualify if:

  • non- new born or infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHOC

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Bernard Choi, PhD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bernard Choi, Ph.D., Assistant Professor Biomedical Engineering

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)