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  • Periodic Reporting for period 1 - 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)
H2020

SIME-LMT Report Summary

Project ID: 666668

Periodic Reporting for period 1 - 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: 2015-04-01 to 2016-03-31

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, non-invasively, 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 are in the middle of a two-year 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 first year of the project, SIME have refined and validated the LMT method and are currently in the process of publishing our most recent observational study in a leading clinical journal. We have also finished building our first LMT prototypes – including the device itself, the software and database, the necessary axillary components and the user interface. We have also begun early-stage dissemination and developed a strategy for market research, which will be conducted in year 2 of the project. Finally, we have completed the clinical study protocol and begun recruiting research partners. The study will start in year 2 of the project with the specific aim of measuring 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. A rapid non-invasive test will allow Neonatologists to quickly identify which babies are at risk minutes after birth and allow them to treat before symptoms present. The earlier these babies are treated the less likely it is that they will develop RDS or any of the related complications. Ultimately, this will have a significant impact on care, chronic disease, mortality and cost.

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