The VISION-Baby study
Research type
Research Study
Full title
The measurement of Vital Signs in neonates and infants by Lifelight software in comparison to the standard of care
IRAS ID
346106
Contact name
Burak Salgin
Contact email
Sponsor organisation
Xim Limited
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a non-invasive basic science study that will meet the study objectives by recruiting at least 256 participants in the neonatal ICU (NICU).
Each participant will have their HR, RR, SpO2, BP, ECG and temperature i.e vital signs (VS) 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 Lifelight (our technology) Data Collect app running on a smartphone positioned above the neonate’s/infant'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.
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. The study will also include a sub-protocol for parents/carers/guardians of eligible participants to complete a post-measurement questionnaire.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/PR/0880
Date of REC Opinion
29 Oct 2025
REC opinion
Further Information Favourable Opinion