The Use of Wireless Sensors in Neonatal Intensive Care

Last updated: November 27, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

ANNE™ Monitoring System (2 sensors) - version C

ANNE™ Monitoring System (2 sensors) - version B

Clinical Study ID

NCT04956354
Wireless NICU
  • Ages 6-1
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy term infants in room air at enrollment

  • Term infants with perinatal asphyxia undergoing therapeutic hypothermia atenrollment

  • 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

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 asepidermolysis bullosa)

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: ANNE™ Monitoring System (2 sensors) - version C
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Montreal Children's Hospital

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

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