The NHS were already facing challenges with unnecessary admissions of term and normal weight babies to the Neonatal Intensive Care Unit (NICU). The Covid-19 pandemic has exacerbated the issue as there is an increase in preterm births and birth complications due to infected mothers. Many of the babies that are being admitted to the NICUs are suffering from hypothermia, a condition that results in the infant's inability to regulate their own temperature. This condition does not require treatment in an expensive incubator, it can be treated in a much simpler and affordable incubator, the mOm Essential. This greater number of admissions means that there is a higher cost to the NHS to treat the baby. Moreover, admitting babies to the NICU means that the baby is separated from the mother and there is overwhelming evidence that the separation of mother and baby so soon after birth can interrupt the normal bonding process. Preventing this separation is an ethical responsibility for healthcare professionals. The mOm Essential is an incubator that is compact, portable, easy to set up and easy to use. The Essential can be assembled on any bed, cot or its own dedicated trolley. The mOm provides warmth and care for the newborn on the delivery ward itself, at a fraction of the price of a standard incubator. This cost-effective solution not only allows the mother to rest and receive her own postpartum care in the maternity unit, but also be comforted by the bedside care of their baby in an incubator. The project objective is to conduct a Summative Study to confirm the observations from previous Formative studies that the mOm incubator is safe and easy to use. We will also need to conduct a randomised multi-site clinical trial which will demonstrate that the mOm incubator delivers the same standard of care as the incubators that are already being used in the hospital. The MHRA have granted us the opportunity of an accelerated pathway to market, through derogation, as they believe that there is a justified need for our device. This grant will help us accelerate the results to prove that our device is safe to use and can provide the same standard of care as existing incubators.

"**mOm Incubators is an award winning social enterprise seeking to enable patient access to high-quality healthcare through affordable technology solutions.** There are over 16,000 newborn infants transferred between hospitals in transport incubators every year in the UK. Incubators provide a warm environment for neonates so that their energy can be spent on development rather than producing heat. Market available neonate and infant transport incubators are either bulky and expensive, or low-cost but stripped of functionality, such as thermoregulation or humidity control. The alternative to a transport incubator is to wrap the baby to the mother on a stretcher inside an ambulance, which is technically illegal and places the baby at high risk of injury in the event of a crash. Perhaps more concerning, recent research has indicated a link between neonatal transport and risk of respiratory distress syndrome and brain injury. Researchers believe this is due to impact and vibrations transferred through the vehicle to the patient. mOm makes the world's only inflatable neonate and infant incubator (www.momincubators.com). Numerous enquiries from within the UK and abroad have indicated significant market demand for a transport-approved version of our innovative incubator. However, stringent standards must be met for use in both road and air ambulances. [][0] We are collaborating with the Aerospace Department at Cranfield University and Morgan Innovation and Technology (MIAT) to redesign the mOm incubator to meet transport safety standards whilst maintaining our low price point and key differentiating advantages (collapsible, infection control, modular). Our consortium brings together leading experts in design (Global Sir James Dyson award winner James Roberts, mOm), electronic and mechanical engineering and innovation (MIAT), impact simulation and crash evaluation (Cranfield). The UK's second largest neonatal transfer service, Embrace, will evaluate the outputs in preliminary field-testing towards the end of the project. We have invested heavily in building an international network of medical device suppliers. Successful project delivery will cement our reputation as leading innovators within the industry and is the first step in an ambitious commercial strategy to disrupt the neonatal incubator market. [0]: http://www.momincubators.com/"

The World Health Organisation (WHO) estimates that 1 million children die needlessly every year due to the complications of premature birth. 75% of these deaths can be prevented overnight with simple treatments such as incubation. Current incubators are incredibly large, needlessly complicated and expensive. mOm was designed to overcome these issues and therefore increase access to incubation services for premature babies world wide. mOm is a low-cost, robust, easy to use compact and energy efficient inflatable infant incubator. Whilst mOm was inspired as a solution for refugee camps, it also has applications in the developing world, in disaster relief zones, during hospital evacuation procedures, in transportation and for use as a precautionary device in geographically disparate areas. We plan to prove the feasibility and safety of the mOm concept in a clinical evaluation that will be carried out in the environment that it is designed for. This will enable us to learn more about how it will be used and whether or not it meets the requirements of an infant incubator so that we can make necessary changes to reach design freeze, achieve regulatory approval and turn mOm into a commercially available product. mOm aims to be a recognised British medtech company that develops and exports novel solutions to solve big problems around the world.

"The World Health Organisation estimates that 1 Million children die due to being born prematurely every year. 75% of these deaths could be solved with simple treatment of which incubation makes up a large part. Incubators have been available for nearly 100 years so why after all this time is there still a huge problem with incubator shortages throughout the developing world? MOM was designed to solve this problem. MOM is an electronically controlled, inexpensive, inflatable incubator designed to decrease the premature death rate throughout the developing world. InnovateUK could help me comply to European standards so I can take MOM from a proven concept to actually helping the people that need them the most."