NEOSONICS – First non-invasive screening medical device for infant meningitis.

During infancy, bacterial meningitis is a very aggressive yet hard-to-detect lethal infection with serious life-long neurological consequences among survivors if left untreated. The innovative NEOSONICS device addresses the challenges associated with meningitis screening in a quick, easy to use, painless and non-invasive manner.

In Europe alone, nearly 2.5 million infants (who are less than one year old) present with fever and by protocol often meningitis needs to be considered as the underlying cause. Although the incidence of meningitis is relatively low, the morbidity and poor prognosis associated with delayed treatment justify lumbar puncture, the only available detection method.

Lumbar puncture is an invasive, cumbersome and time-consuming procedure that is negative in 95 % of cases. While waiting for the results and in cases where a lumbar puncture is not tolerated, infants are hospitalised and receive prophylactic antibiotics for suspected meningitis, costing EU hospitals EUR 1.5 billion every year.

An innovative device

To reduce the unnecessary lumbar puncture procedures, scientists of the EU-funded NEOSONICS project developed an innovative, non-invasive device for detecting meningitis in infants. The device uses a high-resolution ultrasound probe to quickly detect and quantify the white blood cell concentration in the cerebrospinal fluid right below the fontanelle of the baby, the soft spot on the head where the bones are not closed yet. “With this patented technology we want to obtain detailed ultrasound images that allow us to resolve individual cells suspended in the fluid that surrounds the brain and the spinal cord,″ explains project coordinator, founder and CEO of Newborn Solutions, Dr Javier Jiménez.

The white blood cell count will be measured simply with the push of a button. If the count exceeds the very well established thresholds for meningitis, then a lumbar puncture can be performed to draw a sample for bacteriological testing to identify the organism causing the infection. In addition, the device will provide real time information and will be used for monitoring antibiotic treatment response, which is rarely performed given the associated risks of lumbar punctures.

Future applications of the NEOSONICS device

Researchers have shown clinical feasibility of the NEOSONICS screening approach in a small sample of patients with meningitis. Dr Jiménez confesses that, “the results were encouraging enough to push the project forward, seek funding and continue with the development and validation of the technology.″ A total of 28 large EU hospitals in Germany, Spain, France, Italy and United Kingdom as well as a private insurance company in the US and the Spanish National Research Council have confirmed their interest in introducing the NEOSONICS device.

Following prototype development, a proof of concept clinical trial will commence in March 2019 in hospitals in Madrid and Mozambique to demonstrate that the device provides no false negative results. According to Dr Jiménez, “the most significant achievement of the project was building a system that can non-invasively detect meningitis and potentially other infections with unprecedented sensitivity.″

Nowadays, screening for other infections such as arthritis and peritonitis in superficial body fluids also involves invasive procedures. Researchers are confident that the NEOSONICS approach can serve to address such infections, overcoming potential complications and unnecessary costs associated with invasive punctures.

Taken together, the innovative NEOSONICS screening device is expected to revolutionise meningitis diagnosis and decrease the mortality rate of infants in the developing world. In developed countries NEOSONICS will decrease the number of lumbar punctures, unnecessary antibiotics, costs and improve patient care and healthcare system sustainability. In view of the future, Dr Jiménez is hopeful that, “NEOSONICS will help paediatricians provide a quick, easy, painless and cost-effective screening for meningitis in babies.″

Reference source: NEOSONICS – First non-invasive screening medical device for infant meningitis.