Investigation of non-invasive transdermal sensors in neonates V1.1
Research type
Research Study
Full title
Investigation of non-invasive transdermal sensors to replace blood sampling in newborn infants
IRAS ID
218993
Contact name
Neil Patel
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Blood sampling is frequently carried out in the neonatal intensive care unit for monitoring purposes and to inform treatment. Invasive methods used currently are painful and can cause health problems such as anaemia and infection. It is often the most vulnerable infants who require the most frequent blood tests. Development of a non-invasive sensor to replace blood testing could prevent unnecessary distress to infants and reduce the risk of anaemia and infection. It would also benefit healthcare providers by reducing the risk of needle-stick injury and infection to staff and by reducing the amount of laboratory testing and its associated costs.\nThe study aims to see if glucose and lactate diffused through the skin of infants in the neonatal intensive care unit can be used to determine the levels in their blood. \nTwo sensors loaded with gel, similar to ECG electrodes, will be applied to each infant’s flank and left on for one hour to allow glucose and lactate to diffuse into the gel. At the beginning and end of this period, an extremely low electrical current will be applied to measure the skin’s resistance to the flow of electricity which may affect diffusion rates. The sensors will be removed and glucose and lactate concentrations found in the gel will be compared to those measured through invasive blood sampling. This will be repeated up to 5 times over a maximum of 12 days at times chosen to coincide with routine blood sampling. No blood samples will be taken solely for the purposes of the study. The study will take place at the neonatal unit of the Royal Hospital for Children, Glasgow, with laboratory analysis carried out at the University of Strathclyde’s flagship Technology and Innovation Centre.\nThe research is funded by the Glasgow Children’s Hospital Charity Research Fund PhD Studentship.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0165
Date of REC Opinion
19 Mar 2018
REC opinion
Favourable Opinion