Mechanism to Promote Safe and Efficient Oral Feeding in Preterm Infants

促进早产儿安全高效经口喂养的机制

• 批准号: 10396540
• 负责人: Amit Mohan Mathur
• 金额: $ 64.47万
• 依托单位: PREEMIE-PACER, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10396540
• 关键词: Address; Age; Algorithms; Beds; Behavioral; Blood; Breathing; Caregivers; Caring; Charge; Child Rearing; Clinical Trials; Consumption; Cues; Dangerousness; Data; Deglutition; Development; Devices; Drops; Energy Metabolism; Ensure; Failure; Feeds; Goals; Health Professional; Healthcare; Heart Rate; Home; Hospital Costs; Hospitalization; Hour; Individual; Infant; Intake; Interruption; Interview; Laboratories; Length of Stay; Liquid substance; Medical; Memory; Milk; Neonatal; Neonatal Intensive Care Units; Neuraxis; Nipples; Oral; Oral cavity; Outcome; Oxygen; Parents; Pattern; Pediatric Hospitals; Performance; Phase; Physiological; Play; Pregnancy; Premature Infant; Procedures; Process; Protocols documentation; Public Health; Randomized Clinical Trials; Recovery; Respiration; Risk; Running; Safety; Small Business Innovation Research Grant; Stress; System; Techniques; Testing; Time; United States; United States Food and Drug Administration; Work; age group; base; breast pump; commercial application; comorbidity; cost; design; efficacy evaluation; evidence base; experience; feeding; high risk; high risk infant; improved; innovation; prototype; sensor; sex; skills; standard of care; success; sucking; time interval; usability

PROJECT SUMMARY/ABSTRACT There are 380,000 infants born preterm each year in the United States alone. Preterm infants often necessitate care in the neonatal intensive care unit. One of the final milestones to be achieved in order to be discharged from the neonatal intensive care unit is oral feeding. Oral feeding can be a challenge for infants born preterm as they do not have the maturity that allows for coordinated sucking, swallowing, and breathing. Many infants will suck and swallow, and their failure to breathe will result in dangerous physiological fluctuations. To help with this, pacing techniques can be used. Cautious caregivers can intermittently pull the bottle nipple out of the infant’s mouth to encourage breathing and recovery. This can be disruptive to the feeding process, can result in significant energy expenditure, and can be stressful for parents. To address this problem, the Preemie-Pacer bottle is in development. The Preemie-Pacer has an internal mechanism that interrupts the flow of milk to the nipple intermittently to enable the infant to pause and breathe. The long-term goal of this project is to develop an innovative bottle that will address the problems that preterm infants experience during early oral feeding, allowing early feeds to occur safely and efficiently. The current project aims are to 1) optimize the design of the Preemie-Pacer bottle with the addition of an ‘assessment mode’ and internal memory unit, external display, and rechargeable base followed by doing laboratory testing, and 2) improve usability by defining programming for individualized use of the Preemie-Pacer. To achieve this, design work will be followed by laboratory testing of the device to ensure its durability, repeatability and reliability. Then 100 preterm infants born ≤32 weeks gestation will be fed two times each week by a neonatal therapist who will control the flow of milk using a sensor on the bottle, according to the infant’s behavioral signs. Data will be downloaded and pooled and algorithms fit to the data to establish appropriate timing of flow and run across different ages and other infant factors. These evidence-based rates will be incorporated into the bottle programming and will play based on unique infant factors that the feeder enters on the Preemie-Pacer, with the ability to adjust the rates if needed. This work will set the stage for clinical trials on safety and efficacy. The Preemie-Pacer can have a significant impact on the care that preterm infants receive. If safe and efficient oral feeding can be achieved even a few days earlier, significant health care dollars can be saved, and infants can be discharged to their homes earlier. In addition, parents can potentially have more success and confidence in feeding their high-risk preterm infants.

项目概要/摘要 仅在美国每年就有 380,000 名早产婴儿。早产儿通常需要 新生儿重症监护病房的护理。出院所需实现的最后里程碑之一 从新生儿重症监护室出来的是口服喂养。口服喂养对于早产儿来说可能是一个挑战 因为他们还不成熟，无法协调吸吮、吞咽和呼吸。许多婴儿 会吸吮和吞咽，他们无法呼吸会导致危险的生理波动。帮助 在此基础上，可以使用起搏技术。细心的护理人员可以间歇性地将奶嘴从奶瓶中拉出 婴儿的嘴以促进呼吸和恢复。这可能会破坏喂养过程，可能会导致 大量的能量消耗，可能会给父母带来压力。为了解决这个问题，早产儿起搏器 瓶子正在开发中。 Preemie-Pacer 有一个内部机制，可以中断乳汁流向早产儿 间歇性地含住乳头，让婴儿暂停呼吸。 该项目的长期目标是开发一种创新奶瓶，解决早产问题 婴儿在早期经口喂养期间的体验，使早期喂养能够安全有效地进行。目前的 项目目标是 1) 通过添加“评估”来优化 Preemie-Pacer 奶瓶的设计 模式”和内部存储单元、外部显示器和可充电底座，然后进行实验室测试， 2) 通过定义早产儿起搏器的个性化使用编程来提高可用性。为了实现这一目标， 设计工作之后将对设备进行实验室测试，以确保其耐用性、可重复性和 可靠性。那么100名出生≤32周的早产儿将由一名新生儿每周喂养两次 治疗师将根据婴儿的行为，使用奶瓶上的传感器控制乳汁流量 迹象。数据将被下载和汇集，算法将适合数据以建立适当的流程时间 并跨越不同年龄和其他婴儿因素。这些基于证据的比率将被纳入 奶瓶编程，并将根据喂食者在早产儿起搏器上输入的独特婴儿因素进行播放， 如果需要的话能够调整费率。这项工作将为安全性和有效性的临床试验奠定基础。 早产起搏器可以对早产儿接受的护理产生重大影响。如果安全高效的话 甚至可以提前几天实现经口喂养，可以节省大量医疗保健费用，并且婴儿 可以提前出院回家。此外，父母可能会取得更大的成功， 喂养高风险早产儿的信心。