Periodic Reporting for period 2 - Preemie (Personalised nutrition of low-birth-weight infants)
Período documentado: 2020-10-01 hasta 2022-04-30
Each year 500,000 preterm babies are born in Europe out of 15-million worldwide. They often have poor health, with a severe lifetime impact on their quality of life and that of their families. Pre-term birth is a leading cause of lifelong disabilities with high societal economic costs. Inadequate nutrition is the major reason for preterm infants’ ill health. To grow as they would in utero, preterm infants need more nutrition than is provided by their mother’s milk, so the milk needs to be fortified to avoid undernourishment. However, the fortification typically done in Neonatal Intensive Care Units (NICUs) does not take into account the individual differences in the human milk’s composition and the infant’s nutritional needs, which vary with age and weight.
To address this issue, the Preemie project aims at developing the Preemie system, the first rapid, portable, affordable, and easy-to-use milk testing system calibrated with human milk.
The system is able to measure in a rapid and easy way key components in human milk (protein, lipids, carbohydrates, energy, and also lactose and oligosaccharides), the freshness of milk (bacterial load), and the safety (somatic cells count). It also automatically calculates the fortification needed, to reduce workload and human errors in NICUs. Preemie also uses blockchain technology to trace the origin and confirm the authenticity of the donor’s milk. Preemie aims disrupting the existing market by allowing NICUs and human milk banks to scan all donor milk and automatically suggest fortification to be done based on each infant's individual needs, resulting in optimal health.
The main objectives are to develop and commercialize the Preemie system, validating it through a clinical trial in collaboration with a leading European Hospital, obtaining the medical certification needed, and implementing advertising, sales promotions and marketing activities.
To address this issue, the Preemie project aims at developing the Preemie system, the first rapid, portable, affordable, and easy-to-use milk testing system calibrated with human milk.
The system is able to measure in a rapid and easy way key components in human milk (protein, lipids, carbohydrates, energy, and also lactose and oligosaccharides), the freshness of milk (bacterial load), and the safety (somatic cells count). It also automatically calculates the fortification needed, to reduce workload and human errors in NICUs. Preemie also uses blockchain technology to trace the origin and confirm the authenticity of the donor’s milk. Preemie aims disrupting the existing market by allowing NICUs and human milk banks to scan all donor milk and automatically suggest fortification to be done based on each infant's individual needs, resulting in optimal health.
The main objectives are to develop and commercialize the Preemie system, validating it through a clinical trial in collaboration with a leading European Hospital, obtaining the medical certification needed, and implementing advertising, sales promotions and marketing activities.
The first accomplishment has been the development of the Preemie sensor for human milk analysis. The sensor obtained the CE Mark in May 2020 and is currently sold for research purposes. Our sensor received many requests, and we are happy to say that we already sold several units to our customers.
The sensor is user-friendly and easy to use, and also has a unique design which received several prestigious awards: the German Design Award in the Category of Medical, Rehabilitation and Health Care, and the gold prize winner in the Pregnancy and Maternity and the silver prize winner in the Health and Baby Care from the 14th Annual Edition of the International Design Awards (IDA) within the Children’s Product Category.
We started the project with the goal to develop a mobile software just for operating the sensor, but our regular interactions with neonatologists and human milk operators prompted the need to make the most out of the data collected in Neonatal Intensive Care Units and Human Milk Banks. We therefore ended up developing a full software package of four applications, for comprehensive management of infants’ nutrition and for the management and traceability of human milk.
During the project we managed to file four patents to protect our results. We protected the unique design of the Preemie sensor, and we also created and protected our unique cuvette design, the Nurvette, which highly simplifies the sampling activity for analysing human milk. We had the opportunity to enhance and improve our AI platform for data analysis, called SpecAI, and to expand it by including neural networks and deep learning. Today we have a very robust AI platform to perform AI analysis and we filed a patent to protect the Intellectual Property behind SpecAI. The grant also gave us the opportunity to study more in-depth the optimal nutrition for preterm infants, by also taking into account specific diseases that the infant may have and aiming at preventing their occurrence, which resulted in a non provisional patent filed at the end of April 2022.
We performed a Cost-Benefit Analysis to quantify the clinical and economic benefits when adopting the Preemie system and the targeted fortification approach. Our analysis has been published in the Neonatal Intensive Care magazine (Vol. 35 No. 1 Winter 2022) and has been also presented during the 6th International Congress of the European Milk Bank Association (in October 2021).
The Preemie system has been validated in April 2022 for the analysis of lipids, total solids and energy, and we are actively working to finalize our clinical trials and certify the Preemie system as an IVD medical device, which will enable the numerous hospitals and human milk banks which manifested their interest in our solution to adopt it, and finally unleash the personalized fortification approach in their clinical practice.
The sensor is user-friendly and easy to use, and also has a unique design which received several prestigious awards: the German Design Award in the Category of Medical, Rehabilitation and Health Care, and the gold prize winner in the Pregnancy and Maternity and the silver prize winner in the Health and Baby Care from the 14th Annual Edition of the International Design Awards (IDA) within the Children’s Product Category.
We started the project with the goal to develop a mobile software just for operating the sensor, but our regular interactions with neonatologists and human milk operators prompted the need to make the most out of the data collected in Neonatal Intensive Care Units and Human Milk Banks. We therefore ended up developing a full software package of four applications, for comprehensive management of infants’ nutrition and for the management and traceability of human milk.
During the project we managed to file four patents to protect our results. We protected the unique design of the Preemie sensor, and we also created and protected our unique cuvette design, the Nurvette, which highly simplifies the sampling activity for analysing human milk. We had the opportunity to enhance and improve our AI platform for data analysis, called SpecAI, and to expand it by including neural networks and deep learning. Today we have a very robust AI platform to perform AI analysis and we filed a patent to protect the Intellectual Property behind SpecAI. The grant also gave us the opportunity to study more in-depth the optimal nutrition for preterm infants, by also taking into account specific diseases that the infant may have and aiming at preventing their occurrence, which resulted in a non provisional patent filed at the end of April 2022.
We performed a Cost-Benefit Analysis to quantify the clinical and economic benefits when adopting the Preemie system and the targeted fortification approach. Our analysis has been published in the Neonatal Intensive Care magazine (Vol. 35 No. 1 Winter 2022) and has been also presented during the 6th International Congress of the European Milk Bank Association (in October 2021).
The Preemie system has been validated in April 2022 for the analysis of lipids, total solids and energy, and we are actively working to finalize our clinical trials and certify the Preemie system as an IVD medical device, which will enable the numerous hospitals and human milk banks which manifested their interest in our solution to adopt it, and finally unleash the personalized fortification approach in their clinical practice.
The Preemie project intends to develop an innovative system for fast and reliable analysis of human milk. The system will enable nurses and doctors at Neonatal Intensive Care Units to perform targeted fortification of human milk for preterm babies, based on their specific needs. The system will also enable operators at Human Milk Banks to analyse the milk, and keep track of all the history of that milk.
Preemie presents unique advantages with respect to the state-of-the-art solutions:
● Reliable, rapid, and friendly analysis of key human milk components, including protein, carbohydrates, and lipids, with the possibility to expand them to the analysis of the freshness and safety of the milk tested.
● Automatic calculation of the type fortifiers and amounts needed to reach optimal targeted nutrition based on each infant’s specific needs. In current practice, the calculation of the type and amount of fortifiers to be added to the milk is mostly done either manually or through MS Excel, which is cumbersome and prone to human error.
● Possibility to track milk history and data. HMBs collect such data using paper-based or sparse digital tools, and would benefit highly from a comprehensive solution to collect, store, and display data easily and securely. This is needed since the milk provided by milk banks to hospitals is most often pooled from the milk coming from different donors, which makes it difficult to track the various sources and ensure the milk is still fresh and safe. All data can be tracked and stored by Preemie, including the content of the milk, enabling HMBs to provide a digital (and also physical) label to NICUs receiving the milk, thus enhance transparency and traceability of the milk.
● Possibility to test more milk and more often to ensure it is fresh and safe. NICUs may not test all milk for macronutrient content, due to the time and cost of doing so. Often the milk of a donor is tested just at first delivery, and then randomly on the following deliveries from the same donor. A cheap and fast way to test milk would enable to test all the batches received from a donor, but also after every processing occurring in the HMB (after pasteurization), thus ensuring that the milk is fresh and safe.
● Possibility to get unique data-driven insights. Preemie allows users to correlate the actual nutrition administered to the infant to the growth, and take smart decisions on the type of fortification and the fortifiers to be administered. The system also allows to gather data from several infants and understand how the fortification approach and type of fortifiers used can address nutritional and health needs of that group of infants.
Preemie presents unique advantages with respect to the state-of-the-art solutions:
● Reliable, rapid, and friendly analysis of key human milk components, including protein, carbohydrates, and lipids, with the possibility to expand them to the analysis of the freshness and safety of the milk tested.
● Automatic calculation of the type fortifiers and amounts needed to reach optimal targeted nutrition based on each infant’s specific needs. In current practice, the calculation of the type and amount of fortifiers to be added to the milk is mostly done either manually or through MS Excel, which is cumbersome and prone to human error.
● Possibility to track milk history and data. HMBs collect such data using paper-based or sparse digital tools, and would benefit highly from a comprehensive solution to collect, store, and display data easily and securely. This is needed since the milk provided by milk banks to hospitals is most often pooled from the milk coming from different donors, which makes it difficult to track the various sources and ensure the milk is still fresh and safe. All data can be tracked and stored by Preemie, including the content of the milk, enabling HMBs to provide a digital (and also physical) label to NICUs receiving the milk, thus enhance transparency and traceability of the milk.
● Possibility to test more milk and more often to ensure it is fresh and safe. NICUs may not test all milk for macronutrient content, due to the time and cost of doing so. Often the milk of a donor is tested just at first delivery, and then randomly on the following deliveries from the same donor. A cheap and fast way to test milk would enable to test all the batches received from a donor, but also after every processing occurring in the HMB (after pasteurization), thus ensuring that the milk is fresh and safe.
● Possibility to get unique data-driven insights. Preemie allows users to correlate the actual nutrition administered to the infant to the growth, and take smart decisions on the type of fortification and the fortifiers to be administered. The system also allows to gather data from several infants and understand how the fortification approach and type of fortifiers used can address nutritional and health needs of that group of infants.