Apnea of Newborn, Preterm Birth
Conditions
Keywords
Continuous monitoring, NICU, Wireless sensors
Brief summary
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b - monitoring between 2h to 8h per day for 2 to 4 consecutive days, and (c) Phase 2- monitoring for 96h continuously. Study objectives include: 1. Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU. 2. Assess safety of using a special wireless sensor system in neonates. 3. Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.
Detailed description
Infants admitted in the NICU are all subject to continuous monitoring of vital signs such as heart rate, respirations and oxygen saturation (SpO2) by placing sensors, leads, or bands directly on infant's skin and connecting them to monitors via wires. However, despite the rapid technological advances in wireless monitoring and wearable devices across various industries, the health care sector has traditionally lagged. Therefore, the investigators aim to explore the safety and effectiveness of wireless monitoring (ANNE™ Monitoring System) and compare it with the traditional wired monitoring system on infants with variable degrees of maturity in the NICU. More specifically, the investigators aim to examine (1) if it is feasible and to implement a wireless monitoring system in both term and preterm infants in the NICU; (2) if it is safe to use this particular wireless monitoring system among neonates; and (3) the accuracy of the wireless monitoring technology compared to the stand-of-care monitoring in the NICU.
Interventions
DEVICEANNE™ Monitoring System (2 sensors) - version B
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Chest and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - A chest unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and the chest wall movements. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
DEVICEANNE™ Monitoring System (2 sensors) - version C
ANNE™ is a wireless vital sign monitoring device that uses soft, flexible, skin-mountable biosensors (ANNE™ Arc and ANNE™ Limb) with Bluetooth® 5 enabled and encrypted data communication to an iPad application. Study sensors to be applied on patients are: Sensor 1 - ANNE™ Arc with a Lithium-Polymer battery that contains a 6-axial inertial measurement unit (IMU), which includes a 3-axis gyroscope and 3-axis accelerometer, a power management component, an analog front-end component, passive electrodes for ECG, and bio-impedance feature that capture the following waveforms: heart rate (HR), respiratory rate (RR) and skin temperature. Sensor 2 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
McGill University
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy term infants in room air at enrollment * Term infants with perinatal asphyxia undergoing therapeutic hypothermia at enrollment * Healthy preterm infants in room air at enrollment * Preterm infants on continuous positive airway pressure at enrollment * Preterm infants on conventional mechanical ventilation at enrollment * Preterm infants on high frequency ventilation at enrollment * Preterm infants on nasal intermittent positive end expiratory pressure at enrollment * Preterm infants on continuous positive airway pressure at enrollment
Exclusion criteria
* Congenital anomalies and surgical conditions (ex: gastroschisis, omphalocele, congenital diaphragmatic hernia) * Congenital heart disorders * Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of wireless wearable heart rate data | 4 consecutive days of wireless monitoring | Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring. |
| Accuracy of wireless wearable respiratory rate data | 4 consecutive days of wireless monitoring | Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring. |
| Accuracy of wireless wearable skin temperature data | 4 consecutive days of wireless monitoring | Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring. |
| Accuracy of wireless wearable oxygen saturation (SpO2) data | 4 consecutive days of wireless monitoring | Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring. |
| Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts | 4 consecutive days of wireless monitoring | Proportion of monitoring time exhibiting unreliable wireless device signals due to significant movement artifacts. The exact definition of unreliable for each of the signals will be outlined before study initiation. |
| Proportion of time with loss of network connections or other technical problems | 4 consecutive days of wireless monitoring | Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring. |
| Skin integrity at the sites of sensor placement | 4 consecutive days of wireless monitoring | Skin integrity at the site of wireless lead placements from de-identified digital photographs, evaluated by a board-certified dermatologist who will evaluate for signs of irritation, redness and/or erosions. |
| Evaluation of potential subjective pain experienced by infant at time of sensor removal | 4 consecutive days of wireless monitoring | Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal. |
| Clinicians', nursing, and parental perceptions | 4 consecutive days of wireless monitoring | Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Automated reports of physiological health - electrocardiogram | 4 consecutive days of wireless monitoring | Automated reports for electrocardiogram acquired from the wireless monitoring device |
| Automated reports of physiological health - respiratory waveforms | 4 consecutive days of wireless monitoring | Automated reports for respiratory waveforms acquired from the wireless monitoring device |
| Automated reports of physiological health - oxygen saturation | 4 consecutive days of wireless monitoring | Automated reports for oxygen saturation acquired from the wireless monitoring device |
| Automated reports of physiological health - temperature | 4 consecutive days of wireless monitoring | Automated reports for temperature acquired from the wireless monitoring device |
| Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device | 2 to 3 consecutive hours each day during the 4-day continuous monitoring | For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with RIP (the gold standard) with the simultaneously recorded wireless monitoring device data. |
| Enhanced respiratory monitoring using accelerometry | 2 to 3 consecutive hours each day during the 4-day continuous monitoring | For patients in Cohort 2, we will compare the chest and abdominal wall movement signals derived from accelerometry with thoracic impedance (the current standard) with the simultaneously recorded wireless monitoring device data. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORGuilherme M Sant'Anna, MD PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
PRINCIPAL_INVESTIGATORWissam Shalish, MD PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
PRINCIPAL_INVESTIGATORRobert E Kearney, PhD
McGill University
Outcome results
None listed