Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92697
        • UCIMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
premature infant
Laser Speckle Imaging and Diffuse Optical Spectroscopy
Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy
Laser Speckle Imaging and Diffuse Optical Spectroscopy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

  • Principal Investigator: Omid Fathi, MD, Beckman Laser Institute, UCI
  • Study Director: Bernard Choi, PhD, Beckman Laser Institute, UCI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 17, 2013

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20139505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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