The Use of Wireless Sensors in Neonatal Intensive Care

Active, not recruiting

• Conditions: Preterm Birth; Apnea of Newborn

• Registration Number: NCT04956354
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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. 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

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.

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-09
• Study Start: 2022-08-15
• Primary Completion: 2024-09-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of wireless wearable skin temperature data	4 consecutive days of wireless monitoring	Accuracy of wireless wearable skin temperature data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable heart rate data	4 consecutive days of wireless monitoring	Accuracy of wireless wearable heart rate data compared against the current standards of NICU bedside monitoring.
Accuracy of wireless wearable respiratory rate data	4 consecutive days of wireless monitoring	Accuracy of wireless wearable respiratory rate data compared against the current standards of NICU bedside monitoring.
Clinicians', nursing, and parental perceptions	4 consecutive days of wireless monitoring	Clinicians', nursing, and parental perceptions of the implementation of wireless wearable devices in the NICU.
Accuracy of wireless wearable oxygen saturation (SpO2) data	4 consecutive days of wireless monitoring	Accuracy of wireless wearable SpO2 data compared against the current standards of NICU bedside monitoring.
Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts	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.
Skin integrity at the sites of sensor placement	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.
Proportion of time with loss of network connections or other technical problems	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.
Evaluation of potential subjective pain experienced by infant at time of sensor removal	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.

Secondary Outcome Measures

Name	Time	Method
Automated reports of physiological health - oxygen saturation	4 consecutive days of wireless monitoring	Automated reports for oxygen saturation acquired from the wireless monitoring device
Enhanced respiratory monitoring using accelerometry	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.
Automated reports of physiological health - temperature	4 consecutive days of wireless monitoring	Automated reports for temperature acquired from the wireless monitoring device
Automated reports of physiological health - electrocardiogram	4 consecutive days of wireless monitoring	Automated reports for electrocardiogram acquired from the wireless monitoring device
Automated reports of physiological health - respiratory waveforms	4 consecutive days of wireless monitoring	Automated reports for respiratory waveforms acquired from the wireless monitoring device
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	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.

Trial Locations

Locations (1)

Montreal Children's Hospital; 🇨🇦 Montréal, Quebec, Canada