Clinical trial NCT04956354: The Use of Wireless Sensors in Neonatal Intensive Care
Official title: The Use of Wireless Sensors in Neonatal Intensive Care (Wireless NICU)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Preterm Birth
Apnea of Newborn
Keywords: Continuous monitoring
NICU
Wireless sensors
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: McGill University
name: Northwestern University
First posted: 2021-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Accuracy of wireless wearable heart rate data
timeFrame: 4 consecutive days of wireless monitoring
measure: Accuracy of wireless wearable respiratory rate data
timeFrame: 4 consecutive days of wireless monitoring
measure: Accuracy of wireless wearable skin temperature data
timeFrame: 4 consecutive days of wireless monitoring
measure: Accuracy of wireless wearable oxygen saturation (SpO2) data
timeFrame: 4 consecutive days of wireless monitoring
measure: Proportion of time exhibiting unreliable wireless device signals due to significant movement artifacts
timeFrame: 4 consecutive days of wireless monitoring
measure: Proportion of time with loss of network connections or other technical problems
timeFrame: 4 consecutive days of wireless monitoring
measure: Skin integrity at the sites of sensor placement
timeFrame: 4 consecutive days of wireless monitoring
measure: Evaluation of potential subjective pain experienced by infant at time of sensor removal
timeFrame: 4 consecutive days of wireless monitoring
measure: Clinicians', nursing, and parental perceptions
timeFrame: 4 consecutive days of wireless monitoring
Secondary outcomes:
measure: Automated reports of physiological health - electrocardiogram
timeFrame: 4 consecutive days of wireless monitoring
measure: Automated reports of physiological health - respiratory waveforms
timeFrame: 4 consecutive days of wireless monitoring
measure: Automated reports of physiological health - oxygen saturation
timeFrame: 4 consecutive days of wireless monitoring
measure: Automated reports of physiological health - temperature
timeFrame: 4 consecutive days of wireless monitoring
measure: Comparison between chest and respiratory inductance plethysmography (RIP) and the wireless monitoring device
timeFrame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
measure: Enhanced respiratory monitoring using accelerometry
timeFrame: 2 to 3 consecutive hours each day during the 4-day continuous monitoring
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Guilherme M Sant'Anna, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Wissam Shalish, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Robert E Kearney, PhD
role: PRINCIPAL_INVESTIGATOR
References: