Wireless assessment of aEEG Study
The 'Wireless assessment of aEEG Study' is looking at a new, simple, wireless device called Clic EEG that gently sticks to a baby's head to check their brain activity. Doctors currently use a different method called CFM, which involves small wires. This study wants to see if the Clic EEG works as well as CFM and if it could help babies stay with their parents on the postnatal ward, avoiding a trip to the intensive care unit. Researchers will compare the Clic EEG readings with the standard CFM readings. They'll also talk to parents and staff about their experiences with the new device. The study aims to make brain monitoring easier and less disruptive for babies and their families.
At a glance
What is this study about?
Doctors often need to check a baby's brain activity, especially if they're born early or have certain health concerns. This helps them understand how the baby's brain is working and if there are any issues like seizures. Currently, they use a method called 'Cerebral Function Monitoring' (CFM), which involves placing small sticky pads or fine needles on the baby's head, with wires connecting to a monitor.
Researchers are now testing a new, compact, and wireless device called Clic EEG. It's designed to stick gently to the baby's head, like a small plaster, and record brain activity without wires or needles. The main goal of this study is to see if the Clic EEG records brain signals just as accurately as the standard CFM. If it does, it could be a much easier and more comfortable way to monitor babies.
Crucially, if the Clic EEG works well, it might mean that some babies who need their brain activity checked could stay with their parents on the postnatal ward, rather than having to go to a special intensive care unit for closer monitoring. This could help keep families together and reduce stress during a sensitive time.
Key takeaways
- A new wireless device called Clic EEG is being tested to monitor babies' brain activity.
- The study aims to see if Clic EEG works as well as current wired monitoring methods.
- It could potentially help babies stay with their parents on the postnatal ward instead of going to intensive care.
- Some parents may be asked to share their experiences in an online interview.
- The device is non-invasive and uses gentle medical tape.
- The study is backed by the National Institute for Health and Care Research (NIHR).
Who may be eligible?
This study is looking for two types of babies to take part. First, babies who are already in the hospital's special care unit (Neonatal Intensive Care Unit or NICU) and are having their brain activity monitored using the current standard method (CFM). These babies need to be born at 25 weeks of pregnancy or later.
Second, the study is also looking for healthy babies who are born at 36 weeks of pregnancy or later. These babies would be on the standard postnatal ward or in the delivery room. They want to see if the Clic EEG can help these babies be monitored without needing to go to special care.
Babies cannot take part if they have significant swelling or injuries on their scalp, known allergies to sticky plasters, or open wounds, infections, or burns where the device would be placed. Also, babies who are already in other research studies that might interfere with these results cannot join.
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 25 weeks of pregnancy or older?
- Does your baby have healthy skin on their scalp?
- Is your baby already in specialist care (NICU) for brain monitoring?
- Or, is your healthy baby 36 weeks of pregnancy or older and on a regular ward?
- Is your baby NOT already taking part in another research study that might conflict with this one?
What does participation involve?
If your baby takes part, they will have the Clic EEG device gently placed on their head with medical tape. If your baby is already having their brain activity monitored with the standard CFM, the Clic EEG will be used alongside it, usually for 1 to 12 hours. If your baby is on the postnatal ward, both the standard CFM (with three sticky pads) and the Clic EEG will be used for 1 to 6 hours.
After the monitoring, the devices will be carefully removed, and the information collected will be analysed. Your baby will not need to take any medication for this study, and there are no extra follow-up appointments directly related to the device. However, some parents or caregivers, as well as staff, will be invited to an online interview after the baby goes home. These interviews will take about an hour and will be arranged at a convenient time within three weeks of discharge.
Potential risks and benefits
Locations (1)
- St Michael's HospitalApproximateBristol, England
Common questions
What is Clic EEG?
Clic EEG is a new, wireless, small device that sticks to a baby's head to check their brain activity.
Will my baby be hurt by the device?
No, the Clic EEG is designed to be pain-free, using gentle medical tape. Your baby's skin will be checked closely.
How long will the device be on my baby?
It will be on for at least 1 hour, and up to 12 hours if your baby is in intensive care, or up to 6 hours if on the postnatal ward.
Will the results from Clic EEG change my baby's care?
No, for this study, the Clic EEG results are just for research. Your baby's care will still be based on the standard monitoring.
Can I stop participating in the study at any time?
Yes, you are free to withdraw your baby from the study or stop an interview at any point, without affecting your baby's care.
How to find out more
Ela Chakkarapani
Always speak to your GP or specialist before deciding to take part in a study.
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