The Use of Wireless Sensors in Neonatal Intensive Care

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.

Conditions

• Preterm Birth
• Apnea of Newborn

Interventions

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• McGill University

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Guilherme M Sant'Anna, MD PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Wissam Shalish, MD PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Robert E Kearney, PhD · McGill University

Eligibility

Min Age

6 Hours

Max Age

1 Month

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-15

Primary Completion

2024-09-23

Completion

2026-07-31

Countries

• Canada

Study Locations