PREMADES (trademarked as NeoSAFE) 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 preterms’ 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 to 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 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. 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 became ready for the international markets while proving the safeness and effectiveness for preterm infants by conducting multi-site independent clinical trials. During the implementation of the project, it has been validated and verified by the independent test laboratories with respect to related standards and regulations. Additionally, a wide variety of dissemination activities are executed increasing the awareness of key-opinion-leaders, physicians, nurses and general public.
