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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PREMADES (Preterm Feeding Maturity Measurement and Evaluation)

Teaser

Summary

PREMADES is a medical diagnostic device, developed to provide health care practitioners an objective yet noninvasive means for the assessment of feeding maturity. With PREMADES, it is intended to monitor the improvements in the pretermsâ€™ feeding maturity and compare evaluations by regular measurements and analysis, and hence improve clinical decisions.
Swallowing oral nutriments is a complex process, in which 26 muscle pairs, 5 cranial nerves as well as nerves stemming from spinal cord that regulates the movements of chest wall for coordination of breathing and swallowing takes role. Sucking muscles, muscles surrounding the mouth generating sucking pressure, opening and closing of the chin, movement of tongue towards the palate and proceeding of the bolus towards the pharynx are responsible for effective sucking.
Most of the term infants, which were born after the regular gestation period of 37 weeks, have coordinated respiration-sucking-swallowing patterns. However, these are underdeveloped in preterm infants. The lack of development of effective feeding in preterms can cause serious complications such as accidentally aspirated food into the respiratory tract and the lungs, respiratory illnesses related problems like brain hypoxia, infections, respiratory arrest and even death. Further, this can also cause preterm infants get tired very quickly during feeding and thus impact their growth negatively. For these reasons, most of the preterm infants are fed via an orogastric tube in neonatal intensive care units (NICU).
Achievement of effective oral feeding after birth is important for ideal growth and for safe discharge. The exact time at which sucking, swallowing, and respiration become coordinated in preterm infants is still unknown; however, integrity of oropharyngeal anatomy and neurological function is essential to complete the maturation. Preterm infants who are discharged before they have acquired effective feeding skills may be at risk for aspiration, breathing difficulties, or severe respiratory and neurological problems.
Given the aforementioned problems, the crucial need to gain knowledge of the time of maturity of effective feeding in newborns and the importance of monitoring their development is obvious. Today in practice, doctors utilize trial-and-error techniques or observational criteria that are, for the most part, subjective, in order to evaluate the feeding effectiveness and safety. Efforts aimed at more objective assessment techniques have focused on invasive, pressure measurement methods that can be particularly painful for infants. Furthermore, our product is appropriate for point of care testing in NICUs, spreadable and marketable globally. Moreover, it is painless for infants and convenient for the medical staff.
At the end of this project PREMADES will be completely ready for the European and international markets while proving the safeness and effectiveness for preterm infants. Project activities include verification, validation and certification of our product while also conducting independent multi-site clinical trials. Additionally, a wide variety of dissemination activities are planned in order to increase the awareness of key-opinion-leaders, physicians, nurses and general public. Moreover, necessary process standardization efforts will be implemented in order to comply with the required quality and risk management standards of European Medical Device Directive.

Work performed

By the work performed up to now, an optimized and renovated product has been developed which is ready for mass production, validation, clinical trials and certification. Particularly,
- A proprietary main processing electronic board has been developed which, incorporates an ARM CPU with multicore, clock speed over 1 GHz while also including various peripherals and interfaces that can be scaled if required. Board is operated by a Linux based OS and hence enables fast application development.
- A new industrial/mechanical design suitable and feasible for manufacturing is achieved.
- Completely innovative probe and corresponding connector pairs are designed and developed including electronical and mechanical components.
- A non-invasive real-time respiration monitoring functionality is added to the product by utilizing chest/diaphragm and belly movement of the infant.
- In parallel to the hardware developments, software stack including BSP is overhauled.
- Signal processing and machine learning algorithms are improved in terms of the computational complexity and performance.
On the other hand,
- Quality Management System conforming to EN ISO 13485:2016 is established.
- A Risk Management System conforming to ISO 14971:2006 based on FMEA approach is established.
- Configuration Management System is established.
- Complete Critical Design Review conducted and results are incorporated into the design specifications.
- Necessary design specifications for risk and failure mitigations are determined and incorporated into the product design.
- For mass production, suppliers with backup alternatives are determined.
- A worldwide Key-Opinion-Leaders List has been compiled which will be continuously updated.
- Stakeholder (Clinical Research Organizations, Test/Validation Companies, IPR Consultancy Companies, potential Distributor Companies and Investors) relations are developed.
- International Trade Fair, Conference and Symposium participations are achieved which will be boosted in the next period.

Final results

As stated in project proposal, burden of PTB in terms of health and economic issues is still a serious problem for all countries, although the PTB rates are closely related to the socioeconomic statuses of countries. According to World Health Organization (WHO), an estimated 15 million babies are born prematurely every year in the world and it is reported that preterm birth (PTB) amount is rising. In developed countries, PTB constitute 6-12% of all births, whereas in developing countries, this ratio is more than 15%. Tremendous effort is being put in action in order to avoid premature births and improving the well-being of preterms. Hence, it can be easily stated that our endeavor is relevant to the patients, their families and other stakeholders as well as to the medical device market rather easily.
It should be noted that early discharge of preterm infants with feeding disorders results in serious health problems for newborns and causes emotional and physiological damages to their families. Through our interactions and discussions with fellow neonatologists, physicians and experts the aforementioned problems have become more apparent. Seconding the reasoning that the increase in late preterm birth rates have caused an increase in the amount of infant discharges prior to development of respiration-sucking-swallowing coordination. As a result it is observed that in the long term, feeding difficulties can cause growth retardations, neurological disorders and recurring readmissions. The main reasons for these readmissions turn out to be hepatitis and feeding problems. With our product, pretermsâ€™ feeding maturity will be tracked regularly and hence improved clinical decisions will be made.
On top of these, there are some hard facts that have been observed by the public eye (Exhibit A).