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.

项目总结/文摘