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NCT Number: NCT07799870

Vision Baby : 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.

Recruiting

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Key information

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal London Hospital

London, United Kingdom

Location status: Recruiting

Location contact

Burak Salgin, BA MB BChir PhD

CONTACT

[email protected]

+44 (0) 20 7882 5555

Burak Salgin, BA MB BChir PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurence Pearce, MBA

CONTACT

[email protected]

+447803950356

Sponsors and collaborators

Lead sponsor

Xim Limited

Industry

Collaborators

  • Barts & The London NHS Trust

Registry information

Official study title

The Measurement of Vital Signs in Neonates by Lifelight® Software in Comparison to the Standard of Care

Acronym: Vision Baby

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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