Infant Oral Feeding Device for Use in Neonatal Intensive Care Units

描述(申请人提供)：早产儿(&lt；37周妊娠)由于未成熟的吮吸、吞咽、呼吸和低耐力而导致口腔喂养困难。由于能够用口喂养是医院出院的一个标准，它经常被推迟，导致医疗费用增加，母亲压力大，母婴团聚延迟。目前还没有口腔喂养设备来帮助新生儿重症监护病房(NICU)中遇到口腔喂养困难的婴儿。在过去的20年里，PI的研究重点是了解早产儿口腔喂养技能的发展，并开发循证有效的干预/治疗措施，以提高他们的口腔喂养性能。在此期间，她发现，由于两个特定的固有物理特性，传统奶瓶阻碍了婴儿的自然口腔喂养技能。因此，她开发了一种婴儿口腔喂养装置(PreformUm)，证明消除这两个障碍可以使婴儿按照自己的节奏喂养，提高他们的喂养技能，并提高他们的表现，而不会出现不良事件。这部作品出版了。这一第一阶段SBIR应用的目的是开发安全且易于使用的商业版本的PreymUm(S)，并验证其机械和临床性能是否与我们实验室版本的相同。PremiUm将是低成本的，对婴儿安全，易于使用，对照顾者清洁，实用和经济。所使用的材料将满足消费品安全改进法案(CPSIA)和FDA(www.hhs.gov/safe/bpa/)建议的要求。在确认PreymUm的机械性能后，其临床验证将基于2 早产儿组(孕32周)。照顾者和父母将对这项研究视而不见。实验婴儿将被喂以普瑞米乌姆，而他们的对照组婴儿将被喂以与普瑞米乌姆相同的形状、外观和体积的“假”奶瓶。主要结果将是从引入到独立口服喂养的几天时间。次要结果将包括住院时间和费用，以及当婴儿每天服用1-2、3-5和6-8次口服喂养时监测的以下指标：总转移量(总转移量/总转移量)；熟练程度(前5分钟转奶量/总转奶量)；整个喂养过程中的乳汁转移率(毫升/分钟)；喂养持续时间(分钟)；乳汁损失(丢失体积百分比/摄取量)；不良事件的发生。一旦有合适的商业版本可用，将启动PreformUm的生产和商业渗透。它将被引入医院市场，从NICU的婴儿开始，因为这是PI的专业知识所在。它将扩大到所有表现出口腔喂养困难的婴儿，例如先天畸形、发育/智力残疾的婴儿，以及社区中原因不明的奶瓶喂养困难的健康足月婴儿。

DESCRIPTION (provided by applicant): Preterm infants (<37 weeks gestation) have difficulty with oral feeding due to immature suck, swallow, respiration, and low endurance. As the ability to feed by mouth is a criterion for hospital discharge, it is often delayed, leading to increased medical cost, maternal stress, and delayed mother-infant reunification. No oral feeding device currently exists to assist infants in neonatal intensive care units (NICUs) who encounter oral feeding difficulties. The PI's research over the last 20 years has focused on understanding the development of preterm infants' oral feeding skills and developing evidence-based efficacious interventions/therapies to enhance their oral feeding performance. During this time, she identified that conventional bottles hamper infants' natural oral feeding skills due to 2 specific inherent physical properties. As such, she developed an infant oral feeding device (the PreemiUm) demonstrating that the elimination of both hindrances allows infants to feed at their own pace, improves their feeding skills and enhances their performance with no adverse events. This work is published. The aims of this Phase I SBIR application are to develop safe- and simple-to-use commercial version(s) of the PreemiUm and to verify that their mechanical and clinical properties replicate those of our Lab version. The PreemiUm will be low cost, safe for infants, easy to use and clean for caregivers, practical and economical. Material used will meet the requirements recommended by the Consumer Product Safety Improvement Act (CPSIA) and the FDA (www.hhs.gov/safety/bpa/) Following confirmation of the PreemiUm mechanical properties, its clinical validation will be based on the bottle feeding performance of 2 groups of preterm infants (d 32 weeks gestation). Caregivers and parents will be blinded to the study. Experimental infants will be fed with the PreemiUm and their control counterparts with a "sham" bottle identical in shape, looks, and volume as the PreemiUm. The primary outcome will be days from introduction to independent oral feeding. Secondary outcomes will include hospital duration and cost, along with the following measures monitored when infants are taking 1-2, 3-5, and 6-8 oral feedings/day: overall transfer (% total volume taken/ total volume to be taken); proficiency (% volume taken the first 5 min/total volume to be taken); rate of milk transfer over the entire feeding (ml/min); feeding duration (min); milk loss (% volume lost/ volume taken); occurrence of adverse events. Once appropriate commercial versions are available, production and commercial penetration of the PreemiUm will be launched. It will be introduced to the hospital market beginning with infants in NICUs as this is where the PI's expertise lies. It will expand to all infants demonstrating oral feeding difficulties, e.g., those with congenital anomalies, developmental/intellectual disabilities, and healthy term infants in the community with bottle feeding difficulties for unclear reasons.