RecruitingOBSERVATIONAL

Monitoring Key Activity and Physiology of Neonates in Intensive Care

This research is testing a new way to keep an eye on newborn babies in intensive care, particularly those who are experiencing fits or seizures. The study aims to make this new monitoring system, which doesn't directly touch the baby, as good as it can be. We want to see how well it works in a real hospital setting. By using this gentle, non-contact method, doctors hope to get important information about a baby's health and activity more comfortably, which could help them provide better care. The project is focused on making sure this new technology is effective and safe for very young patients.

At a glance

Status

Recruiting

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

01 Aug 2021

Estimated completion

31 Dec 2026

Neonatal Seizure

What is this study about?

This study is all about improving how we look after very young babies who need extra care in hospital, often in a special unit called the Neonatal Intensive Care Unit (NICU). These babies can sometimes have something called a seizure or a 'fit', which means their brain activity temporarily changes. Currently, monitoring babies often involves sticky pads and wires, which can be uncomfortable for delicate newborns.

Researchers are testing brand new equipment that can monitor a baby's body signals without actually touching them. Think of it like a very advanced sensor that can tell what's going on with the baby from a short distance. The main goal is to make sure this new system works really well and gives doctors useful information.

The hope is that by using this gentle, non-contact way of monitoring, babies will be more comfortable, and doctors will still get all the important information they need to understand and treat conditions like seizures. This could lead to better care and outcomes for vulnerable newborns in the future.

Key takeaways

The study tests a new non-contact way to monitor babies in intensive care.
It aims to improve how we detect and understand seizures in newborns.
No new medicines are given; it's purely about observation technology.
Participation will not change your baby's ongoing medical care.
This research hopes to make monitoring more comfortable for delicate babies.

Who may be eligible?

To join this study, the most important thing is that the baby's parents or legal guardians must be happy for them to take part and provide written permission. This is called 'informed consent'. It means they've had all the information explained to them and understand what the study involves.

There aren't any specific age limits, so any baby being cared for in the NICU could potentially be considered. The study is open to both boys and girls.

However, the study is specifically looking at babies in the NICU who might be at risk of, or experiencing, seizures, as this is what they are trying to monitor. There are no other detailed exclusion criteria provided, meaning fewer reasons for a baby not to be included beyond the need for parental permission.

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 my baby currently in the Neonatal Intensive Care Unit (NICU)?
Am I, as a parent or guardian, willing to give written permission for my baby to take part?
Is my baby potentially at risk of, or already experiencing, seizures?
Does my baby have any other medical conditions that might prevent them from joining (though no specific exclusions are listed)?

Answer every question to see your result.

What does participation involve?

If a baby takes part in this study, it means they would be monitored using the new non-contact system while they are already receiving care in the Neonatal Intensive Care Unit (NICU). This monitoring is designed not to interfere with their existing treatment or comfort.

There are no extra visits to the hospital required for this study beyond what the baby already needs for their intensive care. The baby won't be given any new medication specifically for the study. The researchers will simply be using their special equipment to collect information about the baby's activity and body signals while they are in the NICU. The total duration of participation would be while the baby is in the NICU and being monitored by the new system.

Potential risks and benefits

The main benefit of this study could be helping to develop a new, more comfortable way to monitor babies in intensive care, especially those at risk of seizures. This might lead to better and earlier detection of problems, helping doctors provide more timely care. Because the monitoring system doesn't touch the baby, there are very few direct risks mentioned. The study is about observing and not actively changing a baby's care. Parents always have the right to withdraw their baby from the study at any time, for any reason, without it affecting their child's treatment.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is a 'non-contact' monitoring system?

It's equipment that checks a baby's body signals, like their breathing or movements, without having to touch them directly with wires or sticky pads.

Will my baby get any new medicines in this study?

No, your baby will not be given any new medicines as part of this study. It's just about trying out new monitoring equipment.

Will this study change my baby's usual care?

No, this study is designed not to interfere with your baby's normal treatment or care in the Neonatal Intensive Care Unit (NICU).

What happens if we want to leave the study?

You can choose to withdraw your baby from the study at any time, for any reason, and it won't affect their medical care.

What is the NICU?

The NICU stands for Neonatal Intensive Care Unit. It's a special hospital ward for newborn babies who need extra medical attention.

How to find out more

kathryn beardsall

kb274@cam.ac.uk 01223 746791 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.