The Use of Wireless Sensors in Neonatal Intensive Care

NCT04956354 | Active Not Recruiting

• 1 other identifier: Wireless NICU
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 1.Demonstrate the feasibility of continuous wireless monitoring in term and preterm infants with variable degrees of maturation and acuity in the NICU.
2. 2.Assess safety of using a special wireless sensor system in neonates.
3. 3.Evaluate the accuracy of proposed wireless technology as compared to standard monitoring technology in the NICU.

Conditions

Preterm Birth; Apnea of Newborn

Keywords

Continuous monitoring; NICU; Wireless sensors

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Automated reports of physiological health - electrocardiogram

  4 consecutive days of wireless monitoring

• Automated reports of physiological health - respiratory waveforms

  4 consecutive days of wireless monitoring

• Automated reports of physiological health - oxygen saturation

  4 consecutive days of wireless monitoring

• Automated reports of physiological health - temperature

  4 consecutive days of wireless monitoring

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

  2 to 3 consecutive hours each day during the 4-day continuous monitoring

Study Arms (3)

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.

Device: ANNE™ Monitoring System (2 sensors) - version B

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.

Device: ANNE™ Monitoring System (2 sensors) - version C

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.

Device: ANNE™ Monitoring System (2 sensors) - version C

Interventions

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.

Phase 1a

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.

Phase 1b

Eligibility Criteria

• Age: 6 Hours - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• McGill University: collaborator
• Northwestern University: collaborator

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 9, 2021
• Study Start: August 15, 2022
• Primary Completion: September 23, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CA (1)