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Parental BONDing for a better start in life

Periodic Reporting for period 1 - BOND (Parental BONDing for a better start in life)

Reporting period: 2018-12-01 to 2019-11-30

Problem being addressed:
In the EU, 130,000 babies a year are born at a gestational age of less than 32 weeks instead of the normal 40 weeks. As a result of this premature birth, these children (“preemies”) have to spend an average of 42 days in a neonatal intensive care unit (NICU) under close medical observation of vital signs. Even though the environment of the NICU has improved somewhat over time and mortality has decreased over the past decades, one out of two preemies develops concentration problems and/or cognitive impairments. Monitoring the vital signs is essential to increase the survival rate of a preemie.
However, the current wired monitoring setup has some disadvantages. The two main disadvantages are pain and stress (inflicted by the currently used monitoring electrodes), and separation from the mother, which have an adverse effect on cognitive development. Within the current market there are no non-adhesive electrodes and no adhesive electrodes developed specifically for the fragile skin of a preemie; instead, the NICU uses miniaturized versions of the electrodes designed for adults, which carry negative effects when applied to preemies. Bambi is developing the Bambi Belt specifically for preemies to minimise these negative effects. With the Bambi Belt, Bambi offers a solution that aims to become the new gold standard and will overcome the key disadvantages of the current golden standard in monitoring. The Bambi Belt is wireless, allowing a preemie to be taken out of the incubator easily by the parents or nurse and the skin-friendly belt does not damage the skin. This reduces pain and stress and increases the time babies can spend on their mother’s chest. Thus, the duration of preemie hospitalisation will be reduced and health outcomes at a later age will see improvement. The goal of this project is to validate the Bambi Belt in a relevant clinical setting. A clinical study will provide the efficacy data required to register the product and bring the Bambi Belt to the market.

Importance for society:
Main importance for the society is that the Bambi Belt will improve the preemie development and health outcome, which will have an effect from birth throughout childhood development and beyond. The use of the Bambi Belt is anticipated to result in fewer hospitalised days and better cognitive development. This will have a huge direct impact on the preemie and its parents and/or caregivers.
There is also a significant contribution to hospitals and insurance companies.
A hospital, with this improved quality of care, can distinguish itself and, due to the decreased length of stay, fewer NICU beds are needed to provide the same amount of care for preemies within a hospital region. By reducing the amount of hospital beds, a NICU department reduces fixed costs while giving care to the same number of preemies. When the fixed costs of an NICU department are lower and the follow-up medical costs of preemies are lower due to the improved care, healthcare payers will save money in both the short and long term. An additional advantage for the user of the Bambi Belt is the decrease of the required care time by the nurses per preemie.

Overall objectives:
• The scale up of the production of the Bambi Belt to achieve commercial readiness, which includes a cost-effective solution including stretchable electrode carrier, low-power sensors, non-sticky/dry electrodes, and a secure communication protocol as well as a user-friendly wireless handheld monitor compatible with current patient monitors.
• To validate the Bambi Belt in a scaled-up clinical study with preemies performed by key opinion leaders.
• To organise production facilities and achieve CE certification, as preconditions for full-scale EU market introduction. The goal is to obtain a successful market introduction of the Bambi Belt that results in company revenues, to enhance visibility at a global level, and to ensure the technology is developed in line with
Good progress has been made in the areas of product development, clinical validation and dissemination and exploitation. In the area of product development the majority of the technical challenges have been resolved during the reporting period. Remaining challenges for the remainder of the project will be to finalize industrialization of the Bambi Belt solution, perform system integration tests and prepare all documentation which are required for submission to the Notified Body. In addition, Bambi Medical has received the ISO13485:2016 certificate for its quality management system.

With respect to clinical validation, the documentation for the first clinical studies were submitted to the Medical Ethics Committee in preparation for these studies. The studies should provide the first evidence of the performance of the Bambi Belt solution in the intended patient population.

With respect to dissemination and exploitation, the upcoming clinical trials are expected to lead to publications in scientific journals which will help further spread the clinicians’ awareness of the Bambi Belt Solution. In addition to this, multiple conferences and exhibitions will be visited in 2020 and 2021 to show the product to the users.
Main expected results until the end of the project consist of optimization of the current Bambi Belt solution prototypes to the final product, first demonstration as well as clinical validation of the performance of the Bambi Belt in the intended patient population, ramp-up of production and manufacturing facilities, submission for CE certification as per Medical Device Regulation and ultimately obtaining of CE mark from the Notified Body.

With respect to dissemination and exploitation, it is expected to finalize marketing strategy, start marketing operations and market launch within first countries on planning. In addition, it is expected to outreach to medical publications, parent organizations and media (on product readiness) as well as finalize filing of new and/or existing patents.

The impact of the project is described above.
Bambi Belt solution - System Overview