Infant Oral Feeding Device for Use in Neonatal Intensive Care Units

用于新生儿重症监护病房的婴儿口服喂养装置

• 批准号: 8517785
• 负责人: CHANTAL LAU
• 金额: $ 6.89万
• 依托单位: LAU-YEU, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8517785
• 关键词: Abnormal coordination; Academy; Address; Adverse event; American; Apnea; Aspiration Pneumonia; Blinded; Bottle feeding; Bradycardia; Breast Feeding; Cardiovascular system; Caregivers; Childhood; Clinical; Communities; Computer-Aided Design; Consumer Product Safety; Deglutition; Development; Devices; Doctor of Philosophy; Eating Disorders; Elements; Energy Metabolism; Fatigue; Funding; Grant; Growth and Development function; Heart Rate; Hospitalization; Hospitals; Hydrostatic Pressure; Infant; Infant Care; Intellectual functioning disability; Laboratories; Lead; Legal patent; Life; Malnutrition; Marketing; Measures; Mechanics; Medical; Milk; Modeling; Monitor; Morbidity - disease rate; Mothers; Neonatal Intensive Care Units; Oral; Oral cavity; Oxygen; Parents; Pattern; Pediatric Hospitals; Penetration; Performance; Phase; Pregnancy; Premature Infant; Production; Property; Publishing; Research; Research Personnel; Respiration; Safety; Services; Shapes; Small Business Innovation Research Grant; Suspension substance; Suspensions; System; Therapeutic Intervention; Time; Tube; Vacuum; Validation; Weaning; Work; base; commercialization; cost; evidence base; feeding; high risk infant; improved; instrument; interest; maternal stress; meetings; novel; oral motor; physical property; primary outcome; response; secondary outcome; skills; sucking; tube feeding

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.

描述（申请人提供）：早产儿（妊娠<37周）由于吸吮、吞咽、呼吸不成熟和耐力低而存在经口喂养困难。由于能够经口喂养是出院的标准，因此出院时间往往会被推迟，导致医疗费用增加、产妇压力增大、母婴团聚时间延迟。目前尚无口腔喂养装置可以帮助新生儿重症监护病房 (NICU) 中遇到口腔喂养困难的婴儿。 PI 在过去 20 年的研究重点是了解早产儿经口喂养技能的发展，并开发基于证据的有效干预措施/疗法，以提高他们的经口喂养表现。在此期间，她发现传统奶瓶由于两种特定的固有物理特性而阻碍了婴儿的自然口腔喂养技能。因此，她开发了一种婴儿经口喂养装置（PreemiUm），证明消除这两种障碍可以让婴儿按照自己的节奏喂养，提高他们的喂养技巧并提高他们的表现，而不会出现不良事件。这部作品出版了。这一阶段 SBIR 应用的目的是开发安全且易于使用的 PreemiUm 商业版本，并验证其机械和临床特性是否与我们的实验室版本相同。 PreemiUm 成本低廉，对婴儿安全，对护理人员来说易于使用和清洁，实用且经济。使用的材料将符合《消费品安全改进法案》(CPSIA) 和 FDA (www.hhs.gov/safety/bpa/) 推荐的要求。在确认 PreemiUm 机械性能后，其临床验证将基于奶瓶喂养性能2 早产儿组（妊娠 32 周）。照顾者和家长将对这项研究不知情。实验婴儿将用 PreemiUm 喂养，对照婴儿则用形状、外观和体积与 PreemiUm 相同的“假”奶瓶喂养。主要结果将是从引入独立经口喂养开始的几天内。次要结果将包括住院时间和费用，以及婴儿每天口服喂养 1-2 次、3-5 次和 6-8 次时监测的以下措施：总体转移（摄入总量百分比/待摄入总量） ;熟练程度（前 5 分钟所取体积百分比/所取总体积）；整个喂养过程中的奶转移速率（毫升/分钟）；喂食时间（分钟）；牛奶损失（损失量百分比/摄入量）；不良事件的发生。一旦合适的商业版本可用，PreemiUm 的生产和商业渗透将启动。它将首先引入医院市场，首先是 NICU 中的婴儿，因为这是 PI 的专业知识所在。它将扩大到所有表现出经口喂养困难的婴儿，例如先天性异常、发育/智力障碍的婴儿，以及社区中因不明原因而出现奶瓶喂养困难的健康足月婴儿。