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Parental BONDing for a better start in life

Periodic Reporting for period 2 - BOND (Parental BONDing for a better start in life)

Reporting period: 2019-12-01 to 2021-05-31

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 can promote itself and 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.

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 end-user needs and market requirements.

Conclusions of the Action:
Most of the project milestones and deliverables were achieved. The entire system, consisting of a single-use belt and re-usable hardware, has been developed within the period of project BOND. A clinical study with the Bambi Belt solution was successfully completed in the Amsterdam University Medical Center. The product has passed the verification milestone, and will now be validated in two clinical trials (after the end of project BOND). After this, CE Marking will be applied for. The release of the product is expected in 2022.
The following results have been achieved:

- We have developed the end-to-end system that has been approved for clinical trial and has been tested on premature babies. The belt is made of skin-friendly silicone and contains dry electrodes. The handheld monitor has been developed in collaboration with the monitor manufacturer and can be connected to the larger patient monitor of Philips.
- The Bambi Belt has been tested in the First In Man Study that was performed at the Amsterdam University Medical Center. In this study pre-term babies were monitored simultaneously with the current monitoring device (adhesive electrodes) and the Bambi Belt. Based on the good results of the study, we have improved and frozen the algorithm of the system and have filed the documentation for the second clinical trial. The next clinical trials will run after completion of project BOND. These clinical trials will be performed in two Dutch hospitals and will give the results needed as part of the technical file submission to the Notified Body.
- We have secured the manufacturing of all components of the Bambi Belt Solution by engaging three manufacturing partners. The handheld monitor is manufactured by General Meditech Inc., a Chinese (Shenzhen-based) patient monitor manufacturer. The Bambi Bridge and Monitor plug-in are manufactured by Benchmark Electronics, a Dutch (Almelo-based) electronics manufacturer. The Belt is manufactured by Freudenberg Medical, a German (Kaiserslautern-based) silicone injection moulder.
- The Bambi Belt solution is currently in the final phase of development. System verification has been successfully closed and we are now in the validation phase. The expectation is that the product will be launched in Europe in 2022. Currently, in parallel with the clinical activities, our Chief Commercial Officer and Chief Medical Officer are visiting hospitals. During these hospital visits they show the Bambi Belt Solution to the doctors and nurses and gain an understanding of what steps are needed to implement the Bambi Belt Solution in the Neonatal Intensive Care Unit of that hospital. The responses from most hospitals are very promising.
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