Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

NCT ID: NCT01982357

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-17

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Infant, Premature, Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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premature infant

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Intervention Type DEVICE

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Interventions

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Laser Speckle Imaging and Diffuse Optical Spectroscopy

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Omid Fathi, M.D., Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omid Fathi, MD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute, UCI

Bernard Choi, PhD

Role: STUDY_DIRECTOR

Beckman Laser Institute, UCI

Locations

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UCIMC

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20139505

Identifier Type: -

Identifier Source: org_study_id

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