The Preemie-Pacer: An Innovative Bottle to Promote Safe and Efficient Oral Feeding in Preterm Infants

早产儿起搏器：一种促进早产儿安全高效经口喂养的创新奶瓶

• 批准号: 9347983
• 负责人: Thomas Oleksy
• 金额: $ 14.99万
• 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 2017-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9347983
• 关键词: Address; Affect; Age; Arousal; Blood; Breathing; Caregivers; Caring; Child Rearing; Clinical Trials; Cues; Dangerousness; Deglutition; Development; Drops; Energy Metabolism; Engineering; Failure; Feedback; Feeds; Focus Groups; Funding; Goals; Health; Health Professional; Healthcare; Heart Rate; Home environment; Hospital Costs; Hospitalization; Infant; Intake; Interruption; Intravenous; Laboratories; Legal patent; Length; Length of Stay; Liquid substance; Mechanics; Medical; Methods; Milk; Modification; Monitor; Neonatal Intensive Care Units; Neuraxis; Nipples; Noise; Oral; Oral cavity; Outcome; Oxygen; Parents; Pattern; Performance; Phase; Physiological; Pregnancy; Premature Birth; Premature Infant; Procedures; Process; Public Health; Pump; Randomized Clinical Trials; Readiness; Recovery; Respiration; Risk; Safety; Stomach; Stress; Structure; Suction; Techniques; Testing; Time; Tube; United States; Work; age group; base; breast pump; commercialization; cost; design; detector; experience; feeding; high risk; improved; innovation; iterative design; milk expression; new technology; nutrition; prototype; skills; sound; success; sucking; usability; vibration

PROJECT SUMMARY/ABSTRACT There are 450,000 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 being developed. 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 be done safely and efficiently. The project aims are to develop prototypes of the Preemie-Pacer and to assess the acceptability of the Preemie-Pacer among parents of preterm infants and neonatal intensive care unit health care professionals. To achieve this, the concept of the Preemie-Pacer will be converted to 2D and then 3D drawings. Prototypes will be made and modified when they do not meet established design criteria for form and function. Testing will be conducted on a breast pump, and 4 modifications of the original prototype are expected before all established design criteria are met. Focus groups of neonatal intensive care unit professionals and parents will be used to assess the acceptability and to determine additional design needs, and it is expected that one final modification of the prototype will be made after parent and health care professional feedback in order to optimize the design. This work will set the stage for clinical trials in Phase II. 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 450,000 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，从而可以安全有效地进行早期喂养。项目 目的是开发 Preemie-Pacer 原型并评估 Preemie-Pacer 的可接受性 早产儿的父母和新生儿重症监护病房的卫生保健专业人员。为了实现这一目标， Preemie-Pacer 的概念将转换为 2D，然后转换为 3D 图纸。将制作原型并 当它们不符合既定的形式和功能设计标准时进行修改。测试将在 在所有既定的设计标准之前，预计会对原始原型进行 4 次修改 都满足了。由新生儿重症监护病房专业人员和家长组成的焦点小组将用于评估 可接受性并确定额外的设计需求，预计对 将根据家长和医疗保健专业人士的反馈制作原型，以优化设计。这 这项工作将为第二阶段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，可以节省大量医疗费用，并且可以节省婴儿 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。