NCT01982357

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

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

July 17, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

November 5, 2013

Last Update Submit

October 28, 2022

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

  • Normal Blood flow in premature infant

    up to 4 weeks

Study Arms (1)

premature infant

Laser Speckle Imaging and Diffuse Optical Spectroscopy

Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy

Interventions

Laser Speckle Imaging and Diffuse Optical SpectroscopyDEVICE

Laser Speckle Imaging and Diffuse Optical Spectroscopy

premature infant

Eligibility Criteria

Age1 Minute - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • NONE premature infants born or transferred to neonatal intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCIMC

Orange, California, 92697, United States

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Omid Fathi, MD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

  • Bernard Choi, PhD

    Beckman Laser Institute, UCI

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Omid Fathi, M.D., Pediatrics

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 13, 2013

Study Start

July 17, 2013

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)