An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse
The ASPIRE study is investigating how giving extra arginine, a type of nutrient, affects the immune system of newborn babies after major surgery. This includes babies born prematurely or those who have developed a serious gut condition called necrotising enterocolitis. Researchers want to see if different ways of giving arginine – through drips, by mouth, or a combination – can help these vulnerable babies. They will measure arginine levels in the blood and look at how genes involved in nutrition and fighting infection are working. The study hopes to find out if arginine supplementation can lead to better immune responses and recovery. It’s taking place in two hospitals in the UK and will involve 48 babies.
At a glance
What is this study about?
The ASPIRE study is all about understanding how a nutrient called arginine might help tiny babies who've had major bowel surgery or a serious gut problem. Often, these babies are born early (premature) and are very fragile. When babies have surgery, their bodies are under a lot of stress, and their immune system, which fights off infections, needs all the help it can get. This study wants to see if giving extra arginine can boost their immune system and help them heal better.
Researchers will observe how current methods of feeding these babies, both through drips and by mouth, affect their arginine levels. Some babies will also receive extra arginine as a supplement. By looking at blood samples taken at different times, the researchers can measure the amount of arginine in the body. They will also look closely at genes — these are the instructions in our body's cells that tell them what to do. Specifically, they'll check genes involved in how the body handles nutrition and fights off germs.
The main goal is to find out if giving extra arginine can change how these genes work in a positive way, potentially making the babies stronger and better at recovering from surgery or illness. This is an 'exploratory' study, which means it's a first step to learn more about arginine's effects, and it's being conducted in two special baby units within a larger partnership.
Key takeaways
- The ASPIRE study investigates if arginine helps babies after bowel surgery or with gut problems.
- It focuses on premature babies and babies with specific serious conditions.
- Researchers will study how arginine affects baby's immune system and gene activity.
- Some babies will receive arginine supplements, others will get standard care.
- The study aims to improve care for very sick newborns.
Who may be eligible?
This study is looking for very young babies who need major bowel surgery or have been diagnosed with a serious gut condition called necrotising enterocolitis.
This includes babies born prematurely, meaning before 30 weeks of pregnancy. It also includes babies born closer to their due date (after 35 weeks), but only if they need major bowel surgery within the first three days of their life.
Babies would not be able to join the study if they are too unwell and unlikely to survive, have a known problem with their body's metabolism or serious liver issues, or if their parents are unable to give their permission for them to take part.
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 a premature baby (born before 30 weeks)?
- Did my baby need major bowel surgery or have a serious gut problem (NEC)?
- If my baby was born closer to full-term (after 35 weeks), did they need major bowel surgery in the first 3 days of life?
- Does my baby have any serious liver problems or a known genetic condition affecting metabolism?
What does participation involve?
If your baby takes part in this study, they will receive the standard medical care they would normally get. In addition, some babies will receive extra arginine, either through their feeding drip, by mouth, or both, depending on which group they are in.
The study will involve taking some extra blood samples at specific times, up to 30 days after their surgery or diagnosis. These samples will be used to check arginine levels and look at how certain genes are working. Researchers will also keep a close eye on their nutritional intake and other routine blood test results already being collected as part of their care. Consent to participate will ideally be discussed with you before surgery, or within the first 5 days.
Potential risks and benefits
Locations (2)
- Alder Hey Children's HospitalVerified postcodeLiverpool, United Kingdom· Recruiting
- Liverpool Women's HospitalVerified postcodeLiverpool, United Kingdom· Recruiting
Common questions
What is arginine?
Arginine is a natural building block (amino acid) important for many body functions, including healing and the immune system. We get it from food.
Why are you studying arginine in babies?
We want to see if giving extra arginine can help boost the immune system of vulnerable babies recovering from serious surgery or gut conditions.
Will my baby get different treatment if they join?
Your baby will receive all their usual medical care. The only difference is that some babies will also receive an arginine supplement, and we'll take extra blood samples for research.
How long will my baby be in the study?
The study team will collect information for up to 30 days after your baby's surgery or diagnosis. Blood samples will be taken at specific times during this period.
Which hospitals are involved?
This study is happening at Alder Hey Children’s Hospital and Liverpool Women’s Hospital, working together as part of the Neonatal Partnership.
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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