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The Use of Wireless Sensors in Neonatal Intensive Care

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ClinicalTrials.gov Identifier: NCT04956354
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : October 20, 2022
Sponsor:
Collaborators:
McGill University
Northwestern University
Information provided by (Responsible Party):
Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

The study will be conducted in a convenience sample of 48 infants admitted to the NICU at the Montreal Children's Hospital, divided into 2 phases: (a) Phase 1 - monitoring for 8h per day for 4 consecutive days and (b) 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.

Condition or disease Intervention/treatment
Preterm Birth Apnea of Newborn Device: ANNE™ Monitoring System (2 sensors) Device: ANNE™ Monitoring System (3 sensors)

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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
Actual Study Start Date : August 15, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Group/Cohort Intervention/treatment
Phase 1

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.

Device: ANNE™ Monitoring System (2 sensors)

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 tablet 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 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.

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.

Device: ANNE™ Monitoring System (3 sensors)

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 tablet 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 - An abdominal unit (ANNE™ Chest) with embedded battery, sensors, and a three-axis accelerometer that captures the following signals: electrocardiography (ECG), temperature, seismocardiography (SCG) and abdominal wall movements. Only signals of abdominal wall movements will be collected.

Sensor 3 - A limb unit (ANNE™ Limb) with embedded battery that captures the photoplethysmography (PPG) and SpO2 signals.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Hours to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants admitted to the NICU at the Montreal Children's Hospital with different levels of maturity/clinical conditions.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04956354


Contacts
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Contact: Guilherme M Sant'Anna, MD PhD (514)-412-4400 ext 23489 guilherme.santanna@mcgill.ca
Contact: Wissam Shalish, MD PhD (514)-412-4400 ext 22341

Locations
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Canada, Quebec
Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Guilherme Sant'Anna, MD    1-514-412-4400 ext 23489    guilherme.santanna@mcgill.ca   
Principal Investigator: Guilherme Sant'Anna, MD         
Principal Investigator: Wissam Shalish, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
McGill University
Northwestern University
Investigators
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Study Chair: Guilherme M Sant'Anna, MD PhD McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Wissam Shalish, MD PhD McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Robert E Kearney, PhD McGill University
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Responsible Party: Guilherme Sant'Anna, MD, Professor of Pediatrics, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04956354    
Other Study ID Numbers: 2022-7704
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Continuous monitoring
NICU
Wireless sensors
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications