Newborn DistressNCT01166880
A Pilot Study Using Laser Speckle Imaging of Neonate Cerebral Vasculature
An observational study of Newborn Distress, run by University of California, Irvine.
Trial summary
The researcher want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging Read more about this study
- Who is it for?
- Ages 1 minute to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Newborn Distress
- What is being tested?
- Laser Speckle Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Sep 2010
- 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: new born
Who may be able to join
- newborn
Who cannot join
- non-new bron
About this study
Official title: Imaging of Neonate Cerebral Vasculature
The researcher want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging
Read the detailed description
This study involves imaging of superficial blood vessels in the infant's head. Analysis of reflected light images provides the type of data necessary to see the blood vessels.
The researcher want to assess only feasibility of our instrument. If we determine that our instrument has sufficient spatial resolution to image directly large vessels, then we will proceed with plans for a larger study with statistical power.
- Conditions
- Newborn Distress
- Being tested
- Laser Speckle Imaging
- Keywords
- assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle ImagingDevice
Laser Speckle Imaging Infant Head Blood flow
| Study group | Role | What they receive |
|---|---|---|
| Laser Speckle Imaging | Laser Speckle Imaging Infant Head Blood flow Receives: Device: Laser Speckle Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonate Cerebral Blood Flow
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Unable to find grant fundingsupport to continue builds the study device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn DistressStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bernard Choi, PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166880
- Sponsor's protocol ID
- 20097050
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2010
- 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
- Imaging of Neonate Cerebral Vasculature
- ClinicalTrials.gov ID
- NCT01166880
- Acronym / sponsor ID
- 20097050
- Conditions
- Newborn Distress
- Keywords
- assessment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to find grant fundingsupport to continue builds the study device.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Jul 2010 (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.
The researcher want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging
Detailed description
This study involves imaging of superficial blood vessels in the infant's head. Analysis of reflected light images provides the type of data necessary to see the blood vessels.
The researcher want to assess only feasibility of our instrument. If we determine that our instrument has sufficient spatial resolution to image directly large vessels, then we will proceed with plans for a larger study with statistical power.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Speckle Imaging | – | Device: Laser Speckle ImagingLaser Speckle Imaging Infant Head Blood flow |
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- new born
Key inclusion criteria (1 listed)
- newborn
Key exclusion criteria (1 listed)
- non-new bron
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 ImagingLaser Speckle Imaging Infant Head Blood flow | Device | Laser Speckle Imaging |
Primary outcome
Neonate Cerebral Blood Flow
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Bernard Choi, PhD principal investigator
Beckman Laser Institute University of California Irvine
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Distress, run by University of California, Irvine.
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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Neonate Cerebral Blood Flow (time frame: 12 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.