Mechanism to Promote Safe and Efficient Oral Feeding in Preterm Infants
Mechanism to Promote Safe and Efficient Oral Feeding in Preterm Infants
批准号:
10396540
负责人:
Amit Mohan Mathur
金额:
$64.47万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-04-01 至 2024-05-31
关键词:
AddressAgeAlgorithmsBedsBehavioralBloodBreathingCaregiversCaringChargeChild RearingClinical TrialsConsumptionCuesDangerousnessDataDeglutitionDevelopmentDevicesDropsEnergy MetabolismEnsureFailureFeedsGoalsHealth ProfessionalHealthcareHeart RateHomeHospital CostsHospitalizationHourIndividualInfantIntakeInterruptionInterviewLaboratoriesLength of StayLiquid substanceMedicalMemoryMilkNeonatalNeonatal Intensive Care UnitsNeuraxisNipplesOralOral cavityOutcomeOxygenParentsPatternPediatric HospitalsPerformancePhasePhysiologicalPlayPregnancyPremature InfantProceduresProcessProtocols documentationPublic HealthRandomized Clinical TrialsRecoveryRespirationRiskRunningSafetySmall Business Innovation Research GrantStressSystemTechniquesTestingTimeUnited StatesUnited States Food and Drug AdministrationWorkage groupbasebreast pumpcommercial applicationcomorbiditycostdesignefficacy evaluationevidence baseexperiencefeedinghigh riskhigh risk infantimprovedinnovationprototypesensorsexskillsstandard of caresuccesssuckingtime intervalusability
中文摘要
项目总结/摘要
仅在美国,每年就有38万名婴儿早产。早产儿通常需要
新生儿重症监护室的护理。为了出院,最后的里程碑之一
新生儿重症监护室的最后一项措施是口服口服喂养对早产儿来说可能是一个挑战
因为它们还没有成熟到可以协调吮吸、吞咽和呼吸的程度。很多婴儿
会吮吸和吞咽,他们无法呼吸会导致危险的生理波动。帮助
由此可以使用起搏技术。谨慎的护理人员可以间歇性地将奶瓶奶嘴从奶瓶中拔出。
婴儿的嘴,以鼓励呼吸和恢复。这可能会破坏喂食过程,
会消耗大量的能量,这会给父母带来压力。为了解决这个问题,Preemie-Pacer
瓶子正在开发中。Preemie-Pacer有一个内部机制,可以中断乳汁流向
乳头间歇地使婴儿暂停和呼吸。
该项目的长期目标是开发一种创新的奶瓶,以解决早产的问题。
婴儿在早期经口喂养期间的经验,使早期喂养安全有效地发生。当前
该项目的目标是:1)优化Preemie-Pacer瓶的设计,并增加“评估
“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,
以及2)通过定义Preemie-Pacer的个性化使用编程来提高可用性。为了实现这一点,
设计工作完成后,将对设备进行实验室测试,以确保其耐用性、可重复性和
可靠性然后由新生儿每周喂养100例妊娠≤32周的早产儿两次,
治疗师将根据婴儿的行为,使用奶瓶上的传感器控制牛奶的流量。
信号装置.将下载并合并数据,并将算法与数据拟合,以确定适当的流量时间
并跨越不同的年龄和其他婴儿因素。这些基于证据的比率将纳入
奶瓶编程,并将发挥基于独特的婴儿因素,喂食器进入Preemie-Pacer,
如果需要的话,可以调整速率。这项工作将为安全性和有效性的临床试验奠定基础。
Preemie-Pacer可以对早产儿接受的护理产生重大影响。如果安全有效
经口喂养甚至可以提前几天实现,可以节省大量的卫生保健费用,
可以提早出院回家。此外,父母可能会有更多的成功,
喂养高危早产儿的信心。
英文摘要
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.
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依托单位:
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