Enzyme-enhanced safe placement of paediatric nasogastric feeding tubes

This project aims to demonstrate the significant safety and cost benefits of a novel enzyme-enhanced test-strip that rapidly substantiates the correct placement of nasogastric feeding tube in infants and neonates - patient sub-groups for which tube placement errors confer very significant clinical risks and costs. Several hundred thousand nasogastric (NG) feeding tubes are used by the NHS every year in paediatric and neonatal care. Tube misplacements in all patients can and do have disastrous consequences, including patient death. Current safety guidelines and standard UK hospital practice require a test for NG tube aspirate to show pH5.5 or lower prior to feeding or medication, intended to indicate correct stomach location by the presence of gastric hydrochloric acid. The pH test-strips currently employed to this end solely measure gastric HCL and are frequently misinterpreted. This limitation of the only bedside assay currently recommended by the NHS, results in unneccesary confirmatory chest X-rays which, quite apart from being particularly undesirable in infants and neonates, are themselves susceptible to further misinterpretation. In addition to greater clinical risks, the costs are also disproportionately high for this vulnerable patient group. We have developed a novel enzyme-enhanced test-strip to verify correct tube placement which, in recent studies on adult patients in UK hospitals, has proved to be significantly more reliable and accurate than current recommended NHS practice, while lowering costs and requiring no extra user training. The test-strip is innovative in detecting the activity of stomach-specific Human Gastric Lipase enzyme (HGL) to augment the acidic pH response of gastric acid and thereby provide a far more sensitive and selective means to confirm safe and correct NG tube placement. This project will further validate the technical performance of this new test-strip in the infant patient sub-population to quantify its capability to reduce clinical risks, costs and length of hospital stay. Greatly improved safety and reduced confirmatory X-rays in UK paediatric care will prove highly beneficial to the adoption of this new test overseas. Whereas NG tube placement practice worldwide varies greatly for adults, the repeated exposure of infants and neonates to X-rays is universally considered unacceptable. The project will include a non-invasive clinical trial within the paediatric ward at St. Mary's hospital, Paddington, London. Data on clinical utility and health economics will be collected to assess the positive impact of the new test-strip's application and further promote its adoption by the NHS and healthcare providers worldwide.