The mOm Essential Incubator: Neonatal Care for the Covid-19 Pandemic and Beyond

mOm Essential 孵化器：Covid-19 大流行及以后的新生儿护理

• 批准号: 86737
• 金额: $ 12.67万
• 依托单位: MOM INCUBATORS LTD.
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=86737
• 关键词: mOm; Essential; Incubator; Neonatal; Care

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.

NHS 已经面临着不必要地将足月婴儿和正常体重婴儿送入新生儿重症监护病房 (NICU) 的挑战。 Covid-19大流行加剧了这一问题，因为受感染的母亲导致早产和分娩并发症增加。许多入住新生儿重症监护室的婴儿都患有体温过低的情况，这种情况会导致婴儿无法调节自己的体温。这种情况不需要在昂贵的保温箱中进行治疗，可以在更简单且负担得起的保温箱 mOm Essential 中进行治疗。入院人数的增加意味着 NHS 治疗婴儿的费用更高。此外，将婴儿送入新生儿重症监护室意味着婴儿与母亲分离，并且有大量证据表明，母亲和婴儿在出生后这么快就分离会中断正常的亲密关系过程。防止这种分离是医疗保健专业人员的道德责任。mOm Essential 是一款紧凑、便携、易于设置和使用的培养箱。 Essential 可以组装在任何床、婴儿床或专用手推车上。 mOm 为产房内的新生儿提供温暖和护理，其价格只是标准保温箱的一小部分。这种经济高效的解决方案不仅可以让母亲在产房休息并接受自己的产后护理，还可以在保温箱中享受婴儿的床边护理。该项目的目标是进行一项总结性研究，以证实之前形成性研究的观察结果，即 mOm 保温箱安全且易于使用。我们还需要进行一项随机多地点临床试验，以证明 mOm 培养箱提供与医院已使用的培养箱相同的护理标准。 MHRA 通过减损为我们提供了加速进入市场的机会，因为他们认为我们的设备有合理的需求。这笔赠款将帮助我们加速取得成果，以证明我们的设备可以安全使用，并且可以提供与现有孵化器相同的护理标准。