Neonatal Diseases and AbnormalitiesVision BabyNCT07799870
Vision Baby : The Measurement of Vital Signs in Neonates by Lifelight® Software in Comparison to the Standard of Care
An observational study of Neonatal Diseases and Abnormalities and Vital Sign Monitoring, run by Xim Limited at 1 site in United Kingdom.
Trial summary
This is a non-invasive basic science study that will meet the study objectives by recruiting 256 participants in the NICU. The study will also include sub-protocols for parents/carers/guardians of eligible participants to complete post measurement questionnaires. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Neonatal Diseases and Abnormalities, Vital Sign Monitoring
- How many people
- 256 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants (256 participants) in the NICU.
Who may be able to join
- Infants admitted to the NICU (who may subsequently be moved onto a different inpatient ward)
Who cannot join
- Infants who are on a palliative care pathway
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, London
Burak Salgin, BA MB BChir PhD, +44 (0) 20 7882 5555, b.salgin@qmul.ac.uk
Burak Salgin, BA MB BChir PhD
About this study
Official title: The Measurement of Vital Signs in Neonates by Lifelight® Software in Comparison to the Standard of Care
This is a non-invasive basic science study that will meet the study objectives by recruiting 256 participants in the NICU.
The study will also include sub-protocols for parents/carers/guardians of eligible participants to complete post measurement questionnaires.
Read more
Each participant will have their HR, RR, SpO2, BP, ECG and temperature measured continuously using standard of-care equipment and methods. At the same time, video of the participant's face and parts of the torso with exposed skin will be captured 4 times every hour (every 15 minutes) using the Data Collect app running on a tablet positioned above the neonate's cot. The video recorded using the app will be uploaded to the cloud for subsequent analysis and processing aligned to the study's primary and secondary objectives only. The app will not return any measurements to the user or participant.
The video may be recorded for up to 120 seconds each time. There will be a maximum of three attempts at recording measurements.
Most of the data collected will be used to "train" the existing Lifelight algorithms to measure VS in neonates and infants. The remaining data will be kept separate and used to assess the accuracy of the algorithms at regular intervals during the dataset collection period. The study delivery process will be responsive to this learning curve to increase the likelihood that predetermined accuracies for each VS estimation algorithm are achieved by study end.
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the NICU | Patients between the ages 0-1 years will be recruited from the NICU, Royal London Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Collected the data needed to develop Lifelight Baby so that it can measure pulse rate and respiratory rate, and estimate oxygen saturation and blood pressure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Diseases and AbnormalitiesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xim Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Burak Salgin, BA MD BChir PhD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799870
- Sponsor's protocol ID
- 346106
- Acronym
- Vision Baby
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Vital Signs in Neonates by Lifelight® Software in Comparison to the Standard of Care
- ClinicalTrials.gov ID
- NCT07799870
- Acronym / sponsor ID
- Vision Baby / 346106
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Xim LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- 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.
This is a non-invasive basic science study that will meet the study objectives by recruiting 256 participants in the NICU.
The study will also include sub-protocols for parents/carers/guardians of eligible participants to complete post measurement questionnaires.
Each participant will have their HR, RR, SpO2, BP, ECG and temperature measured continuously using standard of-care equipment and methods. At the same time, video of the participant's face and parts of the torso with exposed skin will be captured 4 times every hour (every 15 minutes) using the Data Collect app running on a tablet positioned above the neonate's cot. The video recorded using the app will be uploaded to the cloud for subsequent analysis and processing aligned to the study's primary and secondary objectives only. The app will not return any measurements to the user or participant.
The video may be recorded for up to 120 seconds each time. There will be a maximum of three attempts at recording measurements.
Most of the data collected will be used to "train" the existing Lifelight algorithms to measure VS in neonates and infants. The remaining data will be kept separate and used to assess the accuracy of the algorithms at regular intervals during the dataset collection period. The study delivery process will be responsive to this learning curve to increase the likelihood that predetermined accuracies for each VS estimation algorithm are achieved by study end.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the NICU | – | –Patients between the ages 0-1 years will be recruited from the NICU, Royal London Hospital |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants (256 participants) in the NICU.
Key inclusion criteria (1 listed)
- Infants admitted to the NICU (who may subsequently be moved onto a different inpatient ward)
Key exclusion criteria (1 listed)
- Infants who are on a palliative care pathway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data Collection
Time frame: 2 years
Collected the data needed to develop Lifelight Baby so that it can measure pulse rate and respiratory rate, and estimate oxygen saturation and blood pressure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Burak Salgin, BA MD BChir PhD principal investigator
Barts & The London NHS Trust
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 Neonatal Diseases and Abnormalities and Vital Sign Monitoring, run by Xim Limited at 1 site in United Kingdom.
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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence Pearce, MBA (+447803950356, laurence@xim.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: 2 years). 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 2 Sep 2026.