Wireless MicroPremVitals Button Sensor in the NICU

Официальное название

Miniaturized Vital Sign Monitoring for Preterm Infants in the Neonatal Intensive Care Unit

Обзор

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.

Подробное описание

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:

1. Investigate the feasibility, safety, and accuracy of the Wireless MicroPremVitals Button Sensors monitoring system specifically developed for use in extremely preterm neonates. 2. Assess parents and HCPs perspectives on standard and wireless vital sign monitoring systems in extremely preterm infants.

Вмешательства

• Устройство Wireless MicroPremVitals Button Sensor System
  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.

Первичные конечные точки

• HR Accuracy [Срок оценки: 6 months]
• Oxygen Saturation Accuracy [Срок оценки: 6 months]
• Skin Temperature Accuracy [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Perspectives [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• Montreal Children's Hospital — Montreal

Идентификаторы

NCT: NCT07732257 · Wireless MicroPremVitals

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗