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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorXim Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infants who are on a palliative care pathway

Trial population

Neonates and infants (256 participants) in the NICU.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

256 Participants
are grouped into 1 trial group
Group A: Patients in the NICU

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xim Limited

Lead sponsor

Barts & The London NHS Trust

Collaborator