Active not recruitingOBSERVATIONAL

The Use of Wireless Sensors in Neonatal Intensive Care

This study, taking place in a hospital's neonatal intensive care unit (NICU), is testing a new wireless monitoring system called ANNE™. Currently, babies in the NICU are connected to monitors with wires to check their heart rate, breathing, and oxygen levels. This new system uses wireless sensors instead. The main goals are to find out if this wireless system is safe for babies, if it gives accurate readings compared to the standard wired monitors, and if it's practical to use in the NICU for both full-term and premature infants. Around 75 babies will take part, with different groups being monitored for varying lengths of time, from a few hours a day to continuous monitoring over several days.

At a glance

Status

Active not recruiting

Sponsor

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

Enrolment target

Start

15 Aug 2022

Estimated completion

01 Jul 2026

Preterm Birth Apnea of Newborn

What is this study about?

Imagine your baby is in the hospital's special care unit, often called the NICU. Doctors and nurses need to keep a very close eye on them, especially on important things like their heart rate, how they're breathing, and how much oxygen is in their blood. Right now, this is usually done by attaching small sticky pads or sensors to the baby's skin, which are then connected by wires to a monitor.

This study is looking at a new way to do this using a wireless system, almost like a tiny wearable device for babies. It's called the ANNE™ Monitoring System. The people running the study want to find out three main things: first, if this new wireless system can be easily used for all sorts of babies in the NICU, including those born early (premature) and those born at full term; second, if it's completely safe for babies to use; and third, if the readings it gives are just as accurate and reliable as the readings from the usual wired monitors.

The idea behind this research is to see if wireless monitoring could make things more comfortable for babies and perhaps easier for staff, by reducing the number of wires attached to them. This could be a step towards more modern and less intrusive ways of caring for our most vulnerable newborns. The study is particularly looking at babies who might be born early or have some breathing difficulties.

Key takeaways

A new wireless monitor for babies is being tested.
It aims to replace wired monitors in the NICU.
The study checks for safety, accuracy, and ease of use.
Both full-term and premature babies can take part.
Monitoring lasts up to 4 continuous days.

Who may be eligible?

To join this study, babies need to be between 6 hours and 1 month old. Both boys and girls can take part. The study is looking for a variety of babies, including healthy full-term babies, healthy premature babies, and premature babies who need help with their breathing, such as those on CPAP or ventilators.

However, some babies cannot join the study. This includes babies who have certain major birth defects or conditions that affect their organs, like their heart or bowels. Babies with skin conditions that make their skin very fragile or with certain infections would also not be able to participate. It's important that joining the study wouldn't put any baby at extra risk due to their specific health challenges.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby between 6 hours and 1 month old?
Does your baby NOT have major birth defects like certain heart or gut problems?
Does your baby NOT have fragile skin conditions or severe skin infections?
Is your baby currently in the NICU?
Is your baby either a healthy full-term baby, a healthy premature baby, or a premature baby needing breathing support (like CPAP or a ventilator)?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will have the wireless ANNE™ monitoring system attached. This system uses two small sensors. There are a few different ways your baby might be monitored, depending on which part of the study they're in. Some babies might be monitored for 8 hours a day over four days, others for 2 to 8 hours a day for two to four days, and some might have continuous monitoring for 96 hours (four full days). During this time, the wireless system will simply take readings of their vital signs, which will then be compared to the readings from the standard wired monitors already in place. There are no extra tests or medications involved specifically for this study. The total duration of active monitoring for any individual baby will be a maximum of four days.

Potential risks and benefits

The main potential benefit of taking part is helping to test a new technology that could lead to better and more comfortable monitoring for babies in the future, possibly reducing the number of wires attached to them. As this is a new wireless system, the study is specifically designed to assess its safety, so potential risks are carefully managed. There's a chance of minor skin irritation from the sensors, similar to standard monitor pads. However, the study aims to ensure it's as safe as the current wired monitors. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Montreal Children's Hospital
Verified postcode
Montreal, Canada

Common questions

What is the ANNE™ Monitoring System?

It's a new wireless system with two small sensors designed to monitor a baby's vital signs like heart rate and breathing without needing wires.

Why is this study being done?

The study wants to see if this new wireless monitoring system is safe, accurate, and practical to use for babies in intensive care, compared to the hospital's usual wired monitors.

Will my baby get extra medicine or tests?

No, your baby will not receive any extra medicine or undergo any additional tests just for this study. It's about comparing monitoring methods.

How long will my baby be part of the study?

Depending on the study phase, monitoring could last from a few hours a day over a couple of days, up to a maximum of four continuous days.

Can I take my baby out of the study if I change my mind?

Yes, you can choose to withdraw your baby from the study at any time, and it will not affect their medical care in any way.