Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- HR Accuracy
研究概览
简要总结
A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) to facilitate vital sign monitoring in extremely preterm neonates.
详细描述
Building on prior collaborative work between the Smart Hospital Project and the Dr. John Rogers Laboratory (QSIB- Northwestern University, Chicago, USA) in skin-integrated, soft, flexible electronics for premature infants, these button-sized sensors are designed to provide continuous ECG, oxygen saturation (SpO₂), and skin temperature monitoring without the bulky wires and large adhesives that impact the most fragile infants. By miniaturizing the hardware and tailoring form factor, weight, and interface materials for fragile neonatal skin, the system aims to extend wireless, clinical-grade monitoring down to the smallest, sickest babies.
In the NICU, the possible use of wireless sensors has received positive feedback from parents and HCPs. Overall, the perception is that eliminating the wires and cables will facilitate sensors application and monitoring, improve patient comfort, and skin-to-skin contact between infants and parents.
This proposal aims to:
- Investigate the feasibility, safety, and accuracy of the Wireless MicroPremVitals Button Sensors monitoring system specifically developed for use in extremely preterm neonates.
- Assess parents and HCPs perspectives on standard and wireless vital sign monitoring systems in extremely preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants admitted to the NICU with a gestational age of ≥ 22+0 weeks and ≤ 29+6 weeks at birth,
- •AND >72h of age at time of study,
- •AND clinically stable,
- •AND with the Neonatal Nurse Practitioner (i.e., NNP) and Healthcare Team in agreement for the patient to participate in the study.
排除标准
- •Infants with a skin abnormality that would potentially increase the risk of injury,
- •patient too unstable or family experiencing too much stress as determined by an attending physician or bedside care team to not be approached for recruitment.
- •Infants admitted to the NICU with a gestational age of < 22+0 weeks or > 29+6 weeks at birth,
- •and/or ≤ 72h of age at time of study,
- •and/or not meeting all requirements of clinical stability,
- •and/or with the Neonatal Nurse Practitioner (i.e., NNP)/Healthcare Team in disagreement for the patient to participate in the study.
结局指标
主要结局
HR Accuracy
时间窗: 6 months
Comparison of heart rate measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Oxygen Saturation Accuracy
时间窗: 6 months
Comparison of SpO₂ measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
Skin Temperature Accuracy
时间窗: 6 months
Comparison of skin temperature measured by the Wireless MicroPremVitals Button Sensor System and the Philips IntelliVue MX800.
次要结局
- Perspectives(6 months)
研究者
Guilherme Sant'Anna, MD
Senior Clinician Scientist, Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre