The Use of Wireless Sensors in Neonatal Intensive Care

McGill University

Status: Active, not recruiting

Conditions: Apnea of Newborn; Preterm Birth

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

Study type: Observational

Funder types: Other

Identifiers

NCT04956354

Wireless NICU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 6 hours to 1 month old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

75 participants in 3 patient groups

Phase 1a

Description:

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.

Treatment:

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

Phase 1b

Description:

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.

Treatment:

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

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

Phase 2

Description:

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.

Treatment:

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

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