Low cost wearable overalls for neonatal phototherapy.

Neonatal jaundice is very common in newborns. It is estimated that 80% of newborns have clinical jaundice within the first week of life. Light phototherapy is the most widely used treatment to prevent infant mortality and morbidity rates in jaundiced newborns (NBs). However, its effectiveness depends on factors related not only to the specifications of the phototherapy sources, such as power, wavelength and distance to the NB, but also to operational factors, such as the total dose of radiation administered to the NB (time under phototherapy and largest exposed area). In this sense, discontinuity of treatment, for example, during breastfeeding, when the NB is usually removed from the "light bath", is a common problem detected by health professionals. 

Solution for jaundiced neonates undergoing phototherapeutic treatment and their mothers who are physically distant and prevented from maintaining contact with their babies for much of the time. The mother is sometimes physically prevented from responding to her caregivers. The use of the equipment treating like a jumpsuit on the mother's lap favors thermal regulation (generating economy with the use of incubators), promotes comfort for the baby welcomed by the maternal presence. Being more of the baby will favor the baby's production, stimulate the baby's sucking, emotional regulation, which is the development of a basis for a child's future self-esteem and resilience, capacity for regular emotions and to form intimate relationships, promoting the baby's psychological at this early time. The device can improve the conditions of care, as it prevents the mother from seeing her child far away, blindfolded and undressed, especially during winter days when temperatures are lower. And furthermore, it can favor maternal attachment, and thus be able to nurture the mothers' ability to care for their babies in a self-confident way. Studies point out that precocious early relationships as cognitive children at higher risk of social and common outcomes . The WHO- UNIC recommends that mothers and neonates be removed as little as possible and only for medically justified interventions, which cannot occur in the mother's room.

Solution for jaundiced neonates in phototherapy treatment and their mothers who remain distant and unable to maintain physical contact with their babies for much of the time. The mother is sometimes prevented from responding to her child's physical and emotional needs in order to keep them on treatment. 

The studies tried contact with companies probably more similar, (GE, FANEM, OHMED) but for companies that can be considered as treats one of the request not to protect the largest information because we think of the need for a technology. As institutions involved that have industrial and intellectual property of the technology are UFOP "Universidade Federal de Ouro Preto" located in Ouro Preto in the state of Minas Gerais in Brazil and UNESP "Universidade Estadual Paulista Júlio de Mesquita Filho" located in Botucatu in the state of São Paulo in Brazil. The first version of the device patented by Giselle Lacerda through her master's thesis was made with her advisor Rodrigo Fernando bianchi. And adaptations made in collaboration with Tayomara Ferreira Nascimento and Rodrigo Jensen (UNESP) and implanted to the device by master student Lauro Assis Duarte Junior 

As a prototype device was developed for use in infants, a consultation was made with Anvisa's Parlamentarium as to the need for prior experimental studies in an animal model and for use in humans, health. The response indicated that for devices there would be no such need. However, it would be necessary to submit a prior dossier for analysis and to obtain authorization and registration.  The analysis of the dossier would be costly and for this we would have to open a company. This would be the main barrier to be overcome to obtain the registration of the device and thus be able to use it initially in clinical and later commercial environments. 

We propose a solution for jaundiced neonates on phototherapy treatment and their mothers who remain distant and unable to maintain physical contact with their babies for much of the time. The mother is sometimes prevented from responding to her child's physical and emotional needs to keep them in treatment. The use of the equipment on the mother's lap favors thermal regulation (generating economy with the use of incubators), promotes comfort for the baby welcomed by the maternal presence. Being closer to the baby favors milk production, stimulates the baby's sucking, emotional regulation, which is the basis for a child's future self-esteem and resilience, ability to regulate his emotions and form close relationships, promoting the baby's psychological development at this early stage. The device can improve the conditions of care, as it prevents the mother from seeing her child far away, blindfolded and naked, especially during winter days when temperatures are lower. In addition, it may favor maternal attachment, thus improving the mothers' ability to feel self-confident in caring for their babies. Studies show that poor early relationships put children at greater risk for poor cognitive, social, and emotional outcomes.

Develop implementations and evaluate the thermal comfort and safety for the use of the LED Wearable Device, monitoring its use in an animal model. 

Assemble a new layout of the device, implementing security system, cooling system and the battery system (Power-bank) (UFOP). Maximum time for the goal to be reached: 1 year. Indicators: Obtain product with new design and technical report with laboratory analysis
 To evaluate the thermal comfort and safety for the use of the LED Wearable Device, monitoring the use of the device in an animal model (UNESP). Indicators: Obtaining technical scientific report with thermographic, histological, clinical and dermatological analyses. 
Prepare manual and register a patent with the INPI (UFOP and UNESP) with the tested implementations. Maximum time for reaching the goal: 1 year: Indicators: Registration with the agency. 
Prepare dossier to petition the regulatory agencies for authorization to register and use in research with humans. Maximum time for reaching the goal: 2 years . Indicators: Obtaining the dossier with data from the technical report with laboratory (UFOP) and experimental (UNESP) analyses.
Make use in low-income children and needy hospitals target length: 5 years. 

Assessing the risks and designing the actions. 
Anticipated risks: The future mapped risks are related to the operational research activity, such as supply of supplies and the animals for experimental use, animal health status, negligence in the care and handling of animals in the University's vivarium, which may cause damage or interruption in the execution of the processes. 
Action: Elaboration of a list with other possible suppliers of supplies, requisition and scheduling in advance of the specimens used in the study. Requesting animals from batches with no contamination events, follow-up, handling and continuous monitoring by the zoologist that makes up the team, with support from the unit's veterinarian.
Risk of process design: Possibility of loss caused by inadequate design maintenance and communication of business and management processes and supplies. Action: Minimize the chances of loss by protecting the technology through patents and confidentiality agreements. Look for suppliers of supplies that produce certified material to avoid heating of components due to low quality material.  
Contractual risk: Preparation of adequate contracts formally with appropriate clauses and in compliance with the relevant legislation. Action: Training of the team and support from lawyers specialized in technology transfer to avoid the possibility of loss caused by non-compliance, violation or misinterpretation of regulations and standards.

This system is based on a wearable technology to promote the correct use
and more humanized use of neonatal phototherapy. In this way, a product was obtained that is
biocompatible, flexible, transparent, safe, comfortable, easy to use and clean,
Thus, a biocompatible, flexible, transparent, safe, comfortable, portable and low-cost product, which presents potential for use in neonatal ICUs, was obtained. In addition
In addition, this device has temperature control, radiance within the therapeutic limits of phototherapy
of phototherapy and elasticity modulus compatible with that of human skin. Figure 6.1 illustrates the
application of this device, simulating the conditions of phototherapy, which was named
Oumlight, which in turn describes mother of light. The word Oum comes from Arabic and means mother, and
mothers are key figures in Arab culture, so this word has connotations of high respect and admiration.
and admiration.

The impermeability of the proposed system, as well as
the insulation of electronic components, such as LEDs and wires, in order to facilitate
hygienization and eliminate any kind of contact of the NB with the electrical circuits, was allowed
by welding the PVC-DIDP10 films, using a heat press.
Thus, it was verified that the best welding temperature was Ts = 115 oC, according to the
In this way, the best welding temperature was Ts = 115 oC, according to the analysis of the results obtained with the mechanical tests.
As a way to ensure the safety of the NB in relation to burns from heating the
heating of the LEDs, it was found that the use of water bags was an important solution
to control the temperature of the blanket, presenting temperature values close to ambient
room temperature. In addition, the water bags functioned as a comfortable mattress
to the NB. The radiance tests of the system proposed here aimed to ensure the luminous
luminous efficiency for the phototherapeutic treatment. In this way, it was verified that the use of the water bags
water bags, although very efficient in controlling the temperature, meant a loss of almost 24% of the radiance of the
of the radiance of the LEDs. However, with the addition of aluminum (refractive layer) in the device
these radiance losses represented values lower than 20%. Therefore, the use of
aluminum is considered a viable alternative for use in the device. Finally, the mechanical
mechanical tests of traction of the blanket with "sandwich" structure, i.e., the electronic components
electronic components, wires and aluminum foils were mounted between two water bags made of
PVC-DIDP10 films and thermally welded at a temperature of 115o C did not impair the
mechanical properties (moldability/flexibility and strength) of PVC-DIDP10.

The team is composed of Lauro de Assis Duarte Junior Role Electrical Engineer with experience in electronics; Responsible for assembly, automation and collection of thermal, mechanical and irradiance data, Tayomara Ferreira Nascimento Role Nurse with experience in monitoring phototherapeutic treatment in neonates, responsible for designing and conducting experimental research, application of treatment using the device in experimental model and preparation of dossier and review of manual, Gislelle Lacerda Assist in assembly, testing and data collection and technical analysis of the results of temperature, heat dissipation, irradiance of the device and component safety. Technical elaboration of the project for patent submission and the manual and Rodrigo Fernando Bianchi PhD professor Physicist with experience in electronics. He is one of the creators of the Laboratory of Polymers and Electronic Properties of Materials LAPPEM/UFOP. He has experience in entrepreneurship and in the field of Physics of Materials, working mainly in the research of organic electronic devices.