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NCT Number: NCT04956354

The Use of Wireless Sensors in Neonatal Intensive Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Preterm Birth Apnea of Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

6 hour–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ANNE™ Monitoring System (2 sensors) - version B

Device

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

Device

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.

Primary outcomes

  1. Accuracy of wireless wearable heart rate data

    Time frame: 4 consecutive days of wireless monitoring

    Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.

  2. Accuracy of wireless wearable respiratory rate data

    Time frame: 4 consecutive days of wireless monitoring

    Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.

  3. Accuracy of wireless wearable skin temperature data

    Time frame: 4 consecutive days of wireless monitoring

    Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.

  4. Accuracy of wireless wearable oxygen saturation (SpO2) data

    Time frame: 4 consecutive days of wireless monitoring

    Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.

  5. Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts

    Time frame: 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.

  6. Proportion of time with loss of network connections or other technical problems

    Time frame: 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.

  7. Skin integrity at the sites of sensor placement

    Time frame: 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.

  8. Evaluation of potential subjective pain experienced by infant at time of sensor removal

    Time frame: 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.

  9. Clinicians', nursing, and parental perceptions

    Time frame: 4 consecutive days of wireless monitoring

    Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.

Secondary outcomes

  1. Automated reports of physiological health - electrocardiogram

    Time frame: 4 consecutive days of wireless monitoring

    Automated reports for electrocardiogram acquired from the wireless monitoring device

  2. Automated reports of physiological health - respiratory waveforms

    Time frame: 4 consecutive days of wireless monitoring

    Automated reports for respiratory waveforms acquired from the wireless monitoring device

  3. Automated reports of physiological health - oxygen saturation

    Time frame: 4 consecutive days of wireless monitoring

    Automated reports for oxygen saturation acquired from the wireless monitoring device

  4. Automated reports of physiological health - temperature

    Time frame: 4 consecutive days of wireless monitoring

    Automated reports for temperature acquired from the wireless monitoring device

  5. Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device

    Time frame: 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.

  6. Enhanced respiratory monitoring using accelerometry

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • McGill University
  • Northwestern University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 9, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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