CompletedNot ApplicableInterventional

Developing a new vital sign monitor for newborn babies

This study is trying out a new wireless device called the VS Patch for newborn babies. It's designed to make checking a baby's heart rate, oxygen levels, and temperature easier and quicker. When babies are born, about 1 in 10 need a little extra help, and getting quick, accurate information about them is really important. Current monitors can be slow and have lots of wires. The VS Patch combines all these checks into one small device that sticks to the baby's chest, sending information wirelessly. This could help medical staff give babies the best care faster. We're testing if it works safely and accurately, with the aim of helping future babies.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Nottingham

Enrolment target

Start

01 Nov 2024

Estimated completion

30 Aug 2025

Measure heart rate, blood oxygen levels and temperature in newborn babies

What is this study about?

When a baby is born, sometimes they need a bit of help settling into life outside the womb. This means doctors, nurses, and midwives need to quickly measure important things like their heart rate, how much oxygen is in their blood, and their body temperature. Getting this information quickly and accurately in the first few minutes of life is really important for making sure babies get the best care.

At the moment, checking these vital signs often involves putting separate pieces of equipment on the baby. This can take time and involves lots of wires, which can sometimes get in the way. Our research team is developing a new, single device called the VS Patch. This patch can measure all these important things – heart rate, oxygen, and temperature – at the same time.

The VS Patch is designed to stick gently to a baby's chest and send all the information wirelessly to a monitor. This means no more tangled wires from the baby to the machine. By testing this new device, we hope to find a way for medical staff to get crucial information about newborns much faster and more easily, which could lead to even better care for babies in the future.

Key takeaways

The study is testing a new wireless monitor for newborn babies.
It aims to measure heart rate, oxygen, and temperature more efficiently.
Participation involves wearing the new device alongside standard monitors for up to an hour.
There's no direct benefit for your baby, but it could help future babies.
The study is running from June 2024 to January 2026 and is funded by a UK research body.

Who may be eligible?

This study is looking for newborn babies who are in the labour ward or the special care baby unit, provided they were born after at least 24 weeks of pregnancy. The medical team will also need to believe that the baby is likely to survive.

Babies who are receiving comfort care only, or those who are having special cooling treatment, or who are nearing the end of their life, would not be able to join the study. Also, if a baby has recently had an operation on their chest or upper tummy area, they wouldn't be able to take part. For twins or more, only the first baby born would be eligible.

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 a newborn?
Was your baby born at or after 24 weeks of pregnancy?
Is your baby in the labour ward or special care baby unit?
Does the medical team think your baby has a good chance of survival?
Has your baby not had recent chest or upper tummy surgery?
Is your baby not currently receiving 'comfort care' or special cooling treatment?

Answer every question to see your result.

What does participation involve?

If your baby takes part in the study, a small device called the VS Patch will be gently placed on their chest. At the same time, the normal monitoring devices that are currently used will also be put on your baby. Both the VS Patch and the usual monitors will stay on for up to one hour. Once the monitoring is finished, all special equipment from the study will be carefully removed from your baby. There are no extra hospital visits or long-term check-ups required specifically for this study.

Potential risks and benefits

There isn't a direct benefit for babies who take part in this study, but we hope that the information we gather will help us improve care for newborn babies in the future. The VS Patch uses a light to measure oxygen and heart rate, similar to current devices. It's very unlikely, but there's a small chance this light could cause slight redness on the baby's skin. If this happens, the device would be removed straight away. All equipment used has been checked for safety by hospital experts. You are free to withdraw your baby from the study at any time, for any reason, and this will not affect their medical care.

Locations (1)

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

Nottingham University Hospitals NHS Trust
City only
Nottingham, United Kingdom

Common questions

What is the VS Patch?

It's a new wireless device that can measure a baby's heart rate, oxygen levels, and temperature all at once.

Will my baby get better care if they join?

The study isn't designed to directly benefit your baby, but it aims to improve care for all babies in the future.

How long will the device be on my baby?

The VS Patch will stay on for a short time, up to one hour, alongside the usual monitors.

Is it safe?

Yes, all study equipment has been safely checked by hospital experts. We are watching carefully for any possible issues like skin redness.

Can I change my mind about my baby taking part?

Yes, you can decide to withdraw your baby from the study at any time without it affecting their care.

How to find out more

Don Sharkey

don.sharkey@nottingham.ac.uk +44 1158230602 Official trial record

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