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

Neonatal Diseases and Abnormalities, Vital Sign Monitoring

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.

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United Kingdom