Non-invasive continuous monitoring of metabolites in neonates
Research type
Research Study
Full title
Non-invasive continuous monitoring of metabolites and electrolytes in neonates
IRAS ID
287202
Contact name
Jayanta Banerjee
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Small for gestational age (SGA) babies and babies of maternal gestational diabetes mellitus (GDM) have a severely impaired ability to regulate their glucose load. This can lead to unpredictable and extreme levels of blood glucose from <1 to 15-20 mM within hours. Current clinical methods of measuring blood glucose rely on intermittent blood tests. These can be distressing procedures for new-born babies, and repeated tests often mean that blood transfusions are needed due to the infant’s small blood volume. This is also a problem for blood lactate monitoring, which is vital for detecting poor tissue perfusion in conditions such as sepsis and can lead to delays in treatment with devastating consequences.
Continuous monitoring of glucose and lactate levels in these vulnerable infants would allow earlier detection of deteriorating glycaemic control or the onset of sepsis, allowing earlier interventions to improve long-term patient outcome. Therefore, there is a real need for a non-invasive monitoring device designed specifically for use with these small babies.
This study aims to assess the feasibility of using a non-invasive skin sampling patch coupled to a wearable online analysis system to continuously measure levels of glucose, lactate and electrolytes in natural sweat as a surrogate for invasive blood measurements. We will carry out this feasibility study in SGA and GDM babies. Measurements will be evaluated against intermittent blood tests carried out as part of routine clinical care.
REC name
London - Fulham Research Ethics Committee
REC reference
21/PR/0778
Date of REC Opinion
19 Aug 2021
REC opinion
Further Information Favourable Opinion