Development of a digital diagnostics rapid Lung Maturity Test (LMT) for premature infants, to assist neonatologists in the diagnosis of Respiratory Distress Syndrome at birth

Project Information

SIME-LMT

Grant agreement ID: 666668

DOI

10.3030/666668

Project closed

EC signature date 2 June 2015

Start date 1 April 2015

End date 31 March 2017

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 3 417 674,90

EU contribution

€ 2 864 455,50

Coordinated by

SIME DIAGNOSTICS LIMITED
United Kingdom

Periodic Reporting for period 2 - SIME-LMT (Development of a digital diagnostics rapid Lung Maturity Test (LMT) for premature infants, to assist neonatologists in the diagnosis of Respiratory Distress Syndrome at birth)

Reporting period: 2016-04-01 to 2017-03-31

Summary of the context and overall objectives of the project

SIME LMT is a simple digital test that analyses micro-samples of bodily fluid to determine, noninvasively, lung maturity at birth and help prevent Respiratory Distress Syndrome (RDS). This rapid diagnosis of lung maturity empowers Neonatology teams to deliver optimal care moments after birth. Helping neonatologists to treat this early, before symptoms develop, has the potential to significantly reduce, and even prevent, RDS and Bronchopulmonary Dysplasia (BPD) – two major causes of death in premature infants. This bedside test will give Neonatology teams unprecedented decision support – improving clinical outcomes and patient care while reducing mortality and costs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

SIME have completed the second year of a project funded by Horizon2020. The objectives of this project are:
1. To further validate the LMT method and publish observational study data
2. Build product prototypes and conduct user-testing
3. Develop a cloud infrastructure model to deliver Software as a Service (SaaS)
4. Conduct a clinical trial to measure the impact of the SIME LMT on clinical outcomes

During the second year of the project, SIME have further refined and validated the LMT method and generated new IP for which we are applying for patent protection. We have published our most recent observational study in Acta Paediatrica, a leading journal. We are refining our LMT prototype, including the device itself. In collaboration with Microsoft, we have architected the database using next generation Microsoft Azure components and are integrating this configuration to the user interface. We have also continued our extensive dissemination and have refined our strategy for market research and commercialisation. Finally, we have recruited research partners and commenced an observational clinical trial in Denmark. The aim of this trial is to measure the effect of the LMT test and early treatment on key clinical outcomes.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

RDS is a disease in premature infants that is caused by developmental insufficiency of surfactant production and structural immaturity of the lungs. Every year, an estimated 15 million babies are born preterm – RDS is the leading cause of death in these infants. Diagnosing RDS is a challenge. Neonatologists usually have to wait for symptoms to develop during the first few hours of birth before they can make a clear diagnosis and start treatment; by this stage babies are already sick, increasingly fragile and experiencing distress. Prophylactic treatment is not safe, as it can harm healthy babies. During the past year, new European Guidelines for the Management Respiratory Distress Syndrome highlighted the need for a rapid diagnostic non-invasive test that will allow Neonatologists to quickly identify which babies are at risk minutes after birth and allow them to treat before symptoms present. Within this H2020 project, SIME are developing such a test. Ultimately, it will have a significant impact on care, chronic disease, mortality and cost.

Doctor holding tablet and premature baby