The Use of Wireless Sensors in Neonatal Intensive Care

Preterm Birth Clinical Trial

Official title:

The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956354
• Other study ID #: 2022-7704
• Status: Recruiting
• Start date: August 15, 2022
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Guilherme M Sant'Anna, MD PhD
• Phone: (514)-412-4400
• Email: guilherme.santanna[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Hours to 1 Month

Eligibility

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)

Related Conditions & MeSH terms

• Apnea of Newborn
• Premature Birth
• Preterm Birth

Intervention

Device:
• ANNE™ 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.
• ANNE™ 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.
• ANNE™ 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.

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	McGill University, Northwestern University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of wireless wearable heart rate data	Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.	4 consecutive days of wireless monitoring
Primary	Accuracy of wireless wearable respiratory rate data	Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.	4 consecutive days of wireless monitoring
Primary	Accuracy of wireless wearable skin temperature data	Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.	4 consecutive days of wireless monitoring
Primary	Accuracy of wireless wearable oxygen saturation (SpO2) data	Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.	4 consecutive days of wireless monitoring
Primary	Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts	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.	4 consecutive days of wireless monitoring
Primary	Proportion of time with loss of network connections or other technical problems	Proportion of time with loss of network connections or other technical problems from the wireless wearables vs. the NICU bedside monitoring.	4 consecutive days of wireless monitoring
Primary	Skin integrity at the sites of sensor placement	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.	4 consecutive days of wireless monitoring
Primary	Evaluation of potential subjective pain experienced by infant at time of sensor removal	Assessing infants for presence of acute pain associated with sensor removal by administering Neonatal Infant Pain Scale (NIPS) at time of device removal.	4 consecutive days of wireless monitoring
Primary	Clinicians', nursing, and parental perceptions	Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.	4 consecutive days of wireless monitoring
Secondary	Automated reports of physiological health - electrocardiogram	Automated reports for electrocardiogram acquired from the wireless monitoring device	4 consecutive days of wireless monitoring
Secondary	Automated reports of physiological health - respiratory waveforms	Automated reports for respiratory waveforms acquired from the wireless monitoring device	4 consecutive days of wireless monitoring
Secondary	Automated reports of physiological health - oxygen saturation	Automated reports for oxygen saturation acquired from the wireless monitoring device	4 consecutive days of wireless monitoring
Secondary	Automated reports of physiological health - temperature	Automated reports for temperature acquired from the wireless monitoring device	4 consecutive days of wireless monitoring
Secondary	Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device	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.	2 to 3 consecutive hours each day during the 4-day continuous monitoring
Secondary	Enhanced respiratory monitoring using accelerometry	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.	2 to 3 consecutive hours each day during the 4-day continuous monitoring