SONGBIRD: sensing oxygen saturations using abdominal NIRS (CTOM UK)
Research type
Research Study
Full title
Sensing OxygeN saturations usinG aBdominal NIRS with an Investigational Realtime Device (Songbird) – CTOM UK (Carag Tissue oxygenation Monitor System/CTOM)
IRAS ID
302147
Contact name
Marco Nief
Contact email
Sponsor organisation
Carag
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions associated with low levels of oxygen in tissues. Near infrared spectroscopy (NIRS) is a technique available to non-invasively and safely monitor the tissue oxygenation status, which can be beneficial or live saving for this fragile patient population. Unfortunately, traditional NIRS devices are not designed to work on the abdomen and measure gut oxygen levels: this study will test a novel device designed for application of NIRS on the abdomen of preterm infants. This is important as the most common cause of death in preterm infants after the first few days relates to problems in the gut where low levels of oxygen may cause a serious disease called necrotising enterocolitis (NEC).
NIRS involves shining an infra-red light through the skin. This technique is already widely used in medicine, and the NIRS technique is already widely used in babies to monitor levels of oxygen in the brain. It is considered completely safe. However, current technology is not designed to measure oxygen in the gut. CARAG have developed a device to do this and we plan to test this in a pilot/feasibility technique. The device will be similar to existing monitoring equipment already routinely used for measuring body oxygen levels, but for this study the monitor is placed on the abdomen.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0053
Date of REC Opinion
4 Apr 2022
REC opinion
Favourable Opinion