Neoneur Feeding System Functionality in the Clinic - Investigating Assessment of Quantifying Feeding Functionality in Premature and Cardiac Surgery Neonates in Comparison to Dr. Medoff-Cooper's Past Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Neoneur LLC
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Maturation
研究概览
简要总结
Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial
详细描述
The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =<34 week, extubated by term
- •Infants with CHD: requiring surgery during the first month of life, gestational age > 37 weeks
排除标准
- •Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar < 5 at 5 minutes, short gut syndrome, history of NEC
- •Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for > 4 weeks, requiring additional surgery
结局指标
主要结局
Maturation
时间窗: 6 weeks of data collection
Neoneur 200 measures are corelated to infant maturation in gestational age
Telehealth functionality
时间窗: 6 months
Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home
次要结局
- Respiratory(6 months)