Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - Digi-NewB (Non-invasive monitoring of perinatal health through multiparametric digital representation of clinically relevant functions for improving clinical intervention in neonatal units (Digi-NewB))

Teaser

In the EU around 8% of newborns are preterm births and around 6.5 % have a birth weight of less than 2500g (Europeristat data) meaning that more than 300 000 infants are hospitalised each year in a European neonatal care unit. Prematurity is a developmental period critical to...

Summary

In the EU around 8% of newborns are preterm births and around 6.5 % have a birth weight of less than 2500g (Europeristat data) meaning that more than 300 000 infants are hospitalised each year in a European neonatal care unit. Prematurity is a developmental period critical to later neurobehavioural function. During this period, the risk of sepsis is high with a high risk of mortality and many environmental exposures have been shown to impact long-term neurobehavioural outcomes.
Started in 2016, Digi-NewB is a 4-year EU-funded project that aims to improve care for the newborns in neonatal units by reducing mortality, morbidity and health costs with a better monitoring of sepsis and newborn’s development.
Using the clinical and signal data (cardiac and respiratory traces, video quantification of movement and sound) from a large cohort of hospitalised newborns recordings, Digi-NewB will propose a new decision support system (DSS). This DSS will assist the clinician in his decision-making through non-invasive monitoring of sepsis risk and of cardio-respiratory and neurobehavioral maturations.
Sub-objectives include i) the implementation of a large clinical study that will consists in monitoring more than 700 newborns in 6 different hospitals; this includes the design and setting up of a dedicated data acquisition system acquiring physiological signals and video and sound data ii) the identification of relevant parameters and related composite indices to be displayed on a dedicated interface in neonatology units, and iii) the improvement and validation of the Decision support system with regards to diagnosis relevance and to user experience.
To achieve these goals, a consortium has been constituted, under the coordination of a paediatric clinical network (GCS HUGO-France), with two SME (Voxygen-France and Syncrophi-Ireland) and four university groups with multidisciplinary expertise: in signal processing (INESC-Portugal and LTSI-UR1 France), in multivariate analyses (TUT-Finland) and in user centred design approach (NUIG-Ireland). The clinical study is implemented in Rennes, Angers, Nantes, Brest, Tours.
The proposed new class of monitoring will lead to development of novel preventive and therapeutic strategies to counteract late diagnosis of sepsis and inappropriate evaluation of maturity.

Work performed

Digi-NewB main objective is to propose “a new decision support system (DSS) using non-invasive monitoring for the early diagnosis of sepsis and for an accurate evaluation of cardio-respiratory and sleep/maturation.”
The project concept also includes the development of “Clinically relevant composite indices to the caregivers through the integration of physiological and clinical measures into targeted user-friendly digital representations.”
The key achievements on the 2nd project period are the following:
- A first operational version of the Sepsis prediction system demonstrator, result of the combined efforts from different WPs into a single system. Two first 12h recordings were successfully implemented on a premature newborn included in Digi-NewB study. This demonstrator is able to combine all pieces of the project results in a unified and integrated software solution. Usability testings were held with nurses and doctors to provide ongoing feedback on the interface. Next period will be focused at improving the system performance, its usability and the clinical interpretation.
- A Sepsis risk prediction model with a good performance level, and a maturation model currently development. The current sepsis model provides a result of 0.78. This was made possible thanks to the development of a dedicated research database and to an improved data treatment chain enabling the selection of variables of interest. In this framework, a new marker for Sepsis and maturation coming from physiological signal analysis was discovered, which provides a higher relevance to the final system. The clinical study enabled acquisition of data from more than 435 newborns. Next period will be focused at adding more patients to the database, along specific recruitment and analysis strategies, improving the treatment chain by adding relevant features, and improve the models performances.
- This second period finally contributed to clarify specific exploitation paths and related innovation management strategies for the final system, at an early stage in the system development. In particular, two exploitation pathways were decided for Sepsis and for Maturation. Next period will be focused at building a common Memorandum of Understanding to support coordinator GCS HUGO in driving the next steps.

Final results

The design of a real-time newborn sepsis monitoring device based on a mathematically driven Decision support system using composite indices extracted from video, sound and physiological signal data is unique in the world. The DSS will aim to detect sepsis risk earlier than current monitoring devices by proposing predictions, and will provide valuable insights into cardio-respiratory and sleep maturation of newborns. It follows a non-invasive/contactless approach, an approach that has never been undertaken in paediatrics.

To achieve this objective, a number of scientific advances are being achieved during the project duration:
- Discovery of a new marker for sepsis and maturation for premature newborns
- Early detection of sepsis in premature newborns
- Integrative multi-scale multi-level approach with sepsis and maturation indices including clinical evolution, cardiac and respiratory activities, video and sound analysis, and sleep monitoring
- Improved knowledge on clinical risks monitoring and related treatment decisions, with predictive value
- Integration of user-friendly and robust DSS including software and hardware components
- Implementation of a user-centered approach to achieve a high-quality DSS implementation in neonatology services
At the end of the project, the fully integrated Digi-NewB system will be tested and validated for clinical use and ready to be tested in a European randomized clinical trial.

On the middle term, it is expected that Digi-NewB will bring further scientific progress on accurate evolution of perinatal health, lead to new therapeutic interventions strategies and improve the management of clinical complex situations. It also will lead to reduced health costs by a secured decision on hospital discharge and personalised monitoring.

On the longer term, Digi-NewB’s ambition is to reduce mortality and morbidity in neonatology services by an improved detection and treatment of sepsis, and maturation monitoring. It will aim to be used by a large number of European neonatology services, and evolve with the medical knowledge and user needs.

Website & more info

More info: http://www.digi-newb.eu.