An observational study in Neonatal Diseases and Abnormalities and Vital Sign Monitoring, sponsored by Xim Limited. Recruiting at 1 site in United Kingdom. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Xim Limited · Observational
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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.
110 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 20 are open to participants now.
This study's planned enrollment of 256 is above the median of 75 across 74 observational studies indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities.
Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →Xim Limited is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Neonates and infants (256 participants) in the NICU.
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Exclusion Criteria:
Patients between the ages 0-1 years will be recruited from the NICU, Royal London Hospital
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
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Congenital, Hereditary, and Neonatal Diseases and Abnormalities →
Xim Limited