An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
The SuNDiAL study is looking into how babies recover after having major tummy surgery in their first five days of life. We're interested in conditions like gastroschisis or diaphragmatic hernia. Researchers will measure the levels of two natural substances in the blood, called Arginine and ADMA, which are already part of routine blood tests. They want to see if the balance between these two substances can tell us more about how quickly babies will recover and if they might face any complications. If this balance proves useful, it could help doctors develop new ways to support babies' recovery, like giving them extra Arginine. There are no extra tests or blood samples needed for this study; we only use leftover blood from routine care.
At a glance
What is this study about?
This study, called SuNDiAL, focuses on newborn babies who need major tummy surgery very soon after birth, usually within their first five days. This includes babies born with conditions such as problems with their tummy wall or a hole in their diaphragm (the sheet of muscle that separates the chest from the tummy).
When adults have similar surgeries, the levels of two natural substances in their blood – Arginine and ADMA – can give clues about how well they'll recover. We want to see if the same is true for babies. By measuring these substances, doctors hope to understand better how babies heal and if they might have problems after surgery. If we find a clear link, it could help develop new ways to improve recovery, for example, by giving babies extra Arginine.
It's important to know that this is an 'observational' study. This means doctors are simply watching and measuring things that already happen as part of your baby's routine care. They are not giving any new medicines or doing any extra procedures. Your baby will still get the best standard care. The information we gain could lead to better treatments for babies needing these operations in the future.
Key takeaways
- Study examines babies needing tummy surgery within 5 days of birth.
- Researchers are investigating natural blood substances called Arginine and ADMA.
- Goal is to predict recovery and prevent complications after surgery.
- No extra blood tests or procedures are done for the study; only leftover samples are used.
- Could lead to better care for babies needing similar operations in the future.
- Participation is voluntary and does not affect your baby's care.
Who may be eligible?
Your baby might be able to take part in this study if they were born after 35 weeks of pregnancy and need a major tummy operation for a problem they were born with. This surgery must happen within the first five days of their life.
Also, a parent or guardian must be able to understand written and spoken English well enough to give permission for their baby to join the study.
Babies might not be able to join if they are very unwell and unlikely to survive after surgery, or if they have certain serious liver conditions or metabolic problems. If parents aren't able to give consent, then the baby can't take part either.
- Is my baby born after 35 weeks of pregnancy?
- Does my baby need major tummy surgery for a problem they were born with?
- Will this surgery happen within the first 5 days of their life?
- Am I able to understand and speak English comfortably?
- Does my baby have any other serious health conditions like liver problems or metabolic diseases?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your baby takes part, there will be no changes to their treatment or care. They will receive the standard medical and surgical care recommended by their doctors. The study aims to look at blood leftover from samples already taken for your baby's routine medical checks. No extra blood will be drawn specifically for the study.
Researchers will measure Arginine and ADMA levels from these leftover blood samples before the surgery and several times over the next 30 days, or until your baby has fully recovered, whichever comes first. Your baby's medical records will also be checked to see when they start feeding normally and if they have any complications during their recovery. The total duration of participation for each baby is up to 30 days after their surgery.
Potential risks and benefits
Locations (2)
- Alder Hey Childrens Hospital NSH Foundation TrustLiverpool, United Kingdom· Recruiting
- Liverpool Womens Hospital NHS Foundation TrustLiverpool, United Kingdom· Recruiting
Common questions
What is Arginine and ADMA?
They are natural building blocks found in the body. We're studying if their levels change and what that might mean for recovery after surgery.
Will my baby need extra blood tests for this study?
No, absolutely not. We only use tiny amounts of blood that are left over from routine tests your baby already needs.
How long will my baby be in the study?
Your baby will be part of the study from before their surgery until they fully recover, or for up to 30 days after surgery, whichever is sooner.
Will this study change my baby's treatment?
No, this study will not change any of your baby's medical care or treatment. They will receive the standard care their doctors recommend.
What if I change my mind about my baby participating?
You can decide to withdraw your baby from the study at any time without it affecting their medical care in any way.
How to find out more
Colin Morgan
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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