Infant, Premature, DiseasesNCT01982357
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies
An observational study of Infant, Premature, Diseases, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Laser Speckle Imaging and Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2013to 30 Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study population will be selected from University of California Irvine Medical Center at Neonate Intensive Care Unit
Who may be able to join
- premature infants born or transferred to neonatal intensive care unit with a gestational age of 28-35 weeks
Who cannot join
- NONE premature infants born or transferred to neonatal intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infant, Premature, Diseases
- Being tested
- Laser Speckle Imaging and Diffuse Optical Spectroscopy
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle Imaging and Diffuse Optical SpectroscopyDevice
Laser Speckle Imaging and Diffuse Optical Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| premature infant | Laser Speckle Imaging and Diffuse Optical Spectroscopy Receives: Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Blood flow in premature infant
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start17 Jul 2013
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Omid Fathi, MD, Principal investigator, Beckman Laser Institute, UCIBernard Choi, PhD, Study director, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982357
- Sponsor's protocol ID
- 20139505
- Status last verified
- Oct 2022
- First submitted
- 5 Nov 2013
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies
- ClinicalTrials.gov ID
- NCT01982357
- Acronym / sponsor ID
- 20139505
- Conditions
- Infant, Premature, Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- 17 Jul 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature infant | – | Device: Laser Speckle Imaging and Diffuse Optical SpectroscopyLaser Speckle Imaging and Diffuse Optical Spectroscopy |
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study population will be selected from University of California Irvine Medical Center at Neonate Intensive Care Unit
Key inclusion criteria (1 listed)
- premature infants born or transferred to neonatal intensive care unit with a gestational age of 28-35 weeks
Key exclusion criteria (1 listed)
- NONE premature infants born or transferred to neonatal intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Speckle Imaging and Diffuse Optical SpectroscopyLaser Speckle Imaging and Diffuse Optical Spectroscopy | Device | premature infant |
Primary outcome
Normal Blood flow in premature infant
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omid Fathi, MD principal investigator
Beckman Laser Institute, UCI
Bernard Choi, PhD study director
Beckman Laser Institute, UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Blood flow in premature infant (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.