Measurement of Neonatal Microvascular Hemodynamics Using... | NCT01982357

Studies
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

NCT01982357

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Infant, Premature, Diseases

Interventions

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Countries

United States

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

Oct 2022

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

Jul 17, 2013Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 5, 2013

First Posted Date

Nov 13, 2013Estimated

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

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Omid Fathi, M.D., Pediatrics, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

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

Alterations to microvascular blood flow in premature infants, are known to contribute to several major disease entities.

The optically-measured tissue blood flow, to determine tissue perfusion that can be use to detect blood loss.

Detailed Description

The researchers want to use optical technologies to non-invasively detect blood flow that can tell the onset of blood loss. The research can measure blood flow in stable premature infants in the Neonatal Intensive Care Unit over the duration of several weeks.

The technologies are Laser Speckle Imaging and Diffuse Optical Spectroscopy.

Laser Speckle Imaging non-contact imaging technology, is sensitive to blood flow in superficial tissues. Diffuse Optical Spectroscopy, a probe-based contact technology like pulse oximetry, measures hemoglobin concentrations and states deeper below the skin surface.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
premature infant		Laser Speckle Imaging and Diffuse Optical Spectroscopy	Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Speckle Imaging and Diffuse Optical Spectroscopy	Device	Laser Speckle Imaging and Diffuse Optical Spectroscopy	premature infant

Measure	Description	Time Frame
Normal Blood flow in premature infant		up to 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

premature infants born or transferred to neonatal intensive care unit with a gestational age of 28-35 weeks

Exclusion Criteria:

NONE premature infants born or transferred to neonatal intensive care unit

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Month

Standard Ages

Child

Study Population

Study population will be selected from University of California Irvine Medical Center at Neonate Intensive Care Unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omid Fathi, MD	Beckman Laser Institute, UCI	Principal Investigator
Bernard Choi, PhD	Beckman Laser Institute, UCI	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCIMC		Orange	California	92697	United States

Condition Browse Module

MeSH Terms

ID	Term
D007235	Infant, Premature, Diseases

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081982	Laser Speckle Contrast Imaging

Ancestor Terms

ID	Term
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided