Image

The Use of Wireless Sensors in Neonatal Intensive Care

Recruiting
6 - 1 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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 (ANNEā„¢ 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

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 details

Preterm Birth, Apnea of Newborn

NCT04956354

McGill University Health Centre/Research Institute of the McGill University Health Centre

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.