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NCT01982357 Clinical Trial

Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

Infant, Premature, Diseases Clinical Trial

Official title:
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01982357
Other study ID # 20139505
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 17, 2013
Est. completion date June 30, 2015

Study information
Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date June 30, 2015
Est. primary completion date June 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Minute to 1 Month
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Laser Speckle Imaging and Diffuse Optical Spectroscopy
Laser Speckle Imaging and Diffuse Optical Spectroscopy

Locations
Country Name City State
United States UCIMC Orange California

Sponsors (2)
Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Normal Blood flow in premature infant up to 4 weeks
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