Infant DevelopmentNCT01166867
A Pilot Study Using Photo-plethysmographic (PPG) Camera
An observational study of Infant Development, run by University of California, Irvine at 1 site in United States.
Trial summary
The researcher want to use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light. Read more about this study
- Who is it for?
- Ages 1 minute to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Photo-plethysmography monitoring
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infant
Who may be able to join
- infant and toddler
Who cannot join
- non-infant
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
Official title: Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
The researcher want to use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light.
Read the detailed description
The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window.
- Conditions
- Infant Development
- Being tested
- Photo-plethysmography monitoring
- Keywords
- assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-plethysmography monitoringDevice
monitoring vital sign in infant
| Study group | Role | What they receive |
|---|---|---|
| Infant Development | Photo-plethysmography monitoring Receives: Device: Photo-plethysmography monitoring |
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 startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- 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
- 10 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
- Stuart Nelson, M.D, PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166867
- Sponsor's protocol ID
- 20097046
- 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
- Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
- ClinicalTrials.gov ID
- NCT01166867
- Acronym / sponsor ID
- 20097046
- Conditions
- Infant Development
- Keywords
- assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 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 use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light.
Detailed description
The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant Development | – | Device: Photo-plethysmography monitoringPhoto-plethysmography monitoring |
Who may qualify
- Ages
- 1 minute to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infant
Key inclusion criteria (1 listed)
- infant and toddler
Key exclusion criteria (1 listed)
- non-infant
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 |
|---|---|---|
| Photo-plethysmography monitoringmonitoring vital sign in infant | Device | Infant Development |
Primary outcome
Not reported in the source record.
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.
Stuart Nelson, M.D, PhD principal investigator
Beckman Laser Institute University of California Irvine
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 Development, 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.
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.