SureSat Study
Research type
Research Study
Full title
SureSat: Heart Rate & Oxygen Saturation Monitoring for Newborns
IRAS ID
272658
Contact name
Don Sharkey
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Approximately 7 million babies worldwide, especially premature babies, require advanced resuscitation at birth. Although survival of premature babies is improving, the associated long-term problems remain significant. Monitoring babies' heart rate and oxygen level enables effective resuscitation, improving long term outcomes. Babies with low oxygen level at 5 minutes old have higher chance of dying and bleeding in the brain. Conversely, too much oxygen causes oxygen toxicity, forming substances that are harmful to the lungs, eyes and brain.
Pulse oximeter is placed on babies' right hand at birth to measure oxygen level allowing adjustment of oxygen required. However, current pulse oximeter provides oxygen level readings in a third of babies only by one minute old. It is not designed for newborn babies and face challenges from the limited space to poor blood supply to the hand at birth.
To solve these issues, we can utilise other functions of the CE marked 'SurePulse' device that we developed previously. It is a forehead mounted wireless optical sensor combined within a cap. Currently used to monitor heart rate only, the SurePulse device can also measure oxygen level. SurePulse is anticipated to provide quicker and accurate oxygen level of babies at birth than routine pulse oximeter while keeping babies warm with the integrated cap design. SurePulse will fit naturally into existing resuscitation recommendation.
40 babies will be recruited in Nottingham University Hospitals NHS Trust. 20 babies will be from neonatal unit who require blood test from their artery as part of their routine care. No extra blood test will be done. Oxygen levels from their artery will be compared to SurePulse. The remaining 20 babies will be recruited at or soon after birth. They will be monitored using SurePulse alongside conventional method for up to 30 minutes while undergoing routine delayed clamping of the cord.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0034
Date of REC Opinion
19 Mar 2020
REC opinion
Further Information Favourable Opinion