The Use of Wireless Sensors in Neonatal Intensive Care

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04956354
Study type	Observational
Source	McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact	Guilherme M Sant'Anna, MD PhD
Phone	(514)-412-4400
Email	guilherme.santanna@mcgill.ca
Status	Recruiting
Phase
Start date	August 15, 2022
Completion date	July 2024

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