Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
75 participants
OBSERVATIONAL
2022-08-15
2026-07-31
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Phase 1a
Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for 8h during daytime, for 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal.
Hourly axillary temperature measured by the bedside nurse (as part of routine care) will be manually recorded for each patient by the research team. A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity.
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.
Phase 1b
Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired between 2h to 8h during daytime, for 2 to 4 consecutive days. In addition, photographs of the skin at the site of placement of the sensors will be taken before sensors placement and after removal.
A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity.
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.
Phase 2
Once the setup of the study sensors is complete, clinical and physiological data will be continuously acquired for a longer monitoring period - i.e., 96 consecutive hours. In consideration with device battery life, the devices will be replaced daily. In addition, photographs of the skin at the site of placement of the sensors will be taken at baseline, device replacement, and at 96h. The research team will also measure respirations using uncalibrated RIP belts at the level of the chest and abdomen (2 to 3 continuous hours each day). Two respiratory bands will be placed circumferentially around the infant's chest and around the abdomen to measure chest and abdominal wall movements, respectively.
A temperature and humidity recorder will also be placed around 15cm from the infants to continuously record air temperature and humidity.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 heart disorders
* Congenital skin infections or known conditions with fragile skin (such as epidermolysis bullosa)
6 Hours
1 Month
ALL
Yes
Sponsors
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McGill University
OTHER
Northwestern University
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Guilherme Sant'Anna, MD
Professor of Pediatrics
Principal Investigators
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Guilherme M Sant'Anna, MD PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Wissam Shalish, MD PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Robert E Kearney, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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Montreal Children's Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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Wireless NICU
Identifier Type: -
Identifier Source: org_study_id