Vision Baby : The Measurement of Vital Signs in Neonates by Lifelight® Software in Comparison to the Standard of Care (Vision Baby)

August 27, 2026 updated by: Xim Limited

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laurence Pearce, MBA
  • Phone Number: +447803950356
  • Email: laurence@xim.ai

Study Locations

  • United Kingdom
    • London
      • London, London, United Kingdom
        • Recruiting
        • Royal London Hospital
        • Contact:
        • Principal Investigator:
          • Burak Salgin, BA MB BChir PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates and infants (256 participants) in the NICU.

Description

Inclusion Criteria:

  • Infants admitted to the NICU (who may subsequently be moved onto a different inpatient ward)

Exclusion Criteria:

  • Infants who are on a palliative care pathway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients in the NICU
Patients between the ages 0-1 years will be recruited from the NICU, Royal London Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xim Limited

Collaborators

Barts & The London NHS Trust

Investigators

  • Principal Investigator: Burak Salgin, BA MD BChir PhD, Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 346106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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