Qualitative Study of Surgeons With Prospective Patient Follow-up
This study aims to understand how doctors decide when a premature baby with a serious gut condition, called necrotising enterocolitis (NEC), needs surgery. NEC makes babies very sick, and sometimes parts of their bowel can die. Surgeons must weigh up the risks and benefits of operating on a tiny baby. Researchers will interview surgeons about their decisions and then follow the babies up to see how they get on, looking at their survival, how they feed, and their development as they grow. The goal is to find better ways to decide on surgery and improve care for these vulnerable babies. This research could help ensure babies get the right treatment at the right time.
At a glance
What is this study about?
Necrotising enterocolitis (say: NEK-roh-ty-sing EN-ter-oh-koh-LY-tis), or NEC, is a very serious illness that mostly affects premature babies. It causes a lot of swelling and damage in a baby's bowel, which can make them extremely ill. Sometimes, parts of the bowel can even die. Sadly, even with intensive care, about a third of the sickest babies don't survive, and many who do can have serious health problems later on.
Deciding if and when to perform surgery on a tiny, premature baby with NEC is a very difficult decision for doctors. There are no clear rules, and surgeons have to carefully think about the good and bad points of doing an operation. Operating too late can be harmful, but surgery itself carries risks for such a fragile baby. This can sometimes lead to delays in surgery, which might mean worse outcomes for the baby. This study wants to understand exactly how surgeons make these tough decisions.
To do this, researchers will talk to surgeons shortly after they've decided whether to operate on a baby with NEC. They will then ask the baby's parents for permission to follow the baby's health over time. This includes looking at things like whether the baby survives, how well they can feed, whether they need more operations, and how they are developing by the age of two. By learning more about surgical decisions and how they affect babies' long-term health, this study hopes to find ways to improve care and outcomes for babies with NEC.
Key takeaways
- The study focuses on critical decisions about surgery for premature babies with NEC.
- Researchers will interview surgeons and follow babies' health development for up to two years.
- No extra hospital visits or tests are needed for participating babies.
- The goal is to improve surgical decision-making and long-term health for babies with NEC.
- Your baby's privacy is protected, and participation is voluntary.
Who may be eligible?
This study is looking for babies who have been diagnosed, or are suspected to have, necrotising enterocolitis (NEC) and have been reviewed by a specialist surgeon.
To be included, the surgeon treating your baby would need to agree to be interviewed about the decision they made regarding your baby's treatment (whether to operate or not). Then, you, as the baby's parent or guardian, would need to agree for your baby's health information to be followed up and used in the study.
Babies would not be included if either the surgeon doesn't agree to be interviewed, or if the parents don't give permission for their baby's health information to be used for the study. The study focuses on babies from birth up to four months old.
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.
- Has your baby been reviewed by a surgeon for suspected or confirmed NEC?
- Is your baby currently 4 months old or younger?
- Is your baby's surgeon willing to participate in an interview about their decision-making?
- Are you, as the parent or guardian, willing to allow your baby's health data to be used for research?
What does participation involve?
If you and your baby's surgeon agree to take part, the surgeon will be interviewed by the research team shortly after making a decision about your baby's treatment for NEC. This interview will help the researchers understand how these decisions are made.
Then, with your permission, the research team will track your baby's health progress using information that is already collected as part of their routine care. This means you won't need to attend extra hospital visits or have additional tests specifically for this study. The researchers will follow your baby's journey for about two years to see how they develop and thrive, without any direct interaction from you or your baby after initial consent.
Potential risks and benefits
Locations (1)
- University Southampton NHS Foundation TrustVerified postcodeSouthampton, United Kingdom· Recruiting
Common questions
What is necrotising enterocolitis (NEC)?
NEC is a very serious bowel illness that mainly affects premature babies, causing severe inflammation and damage to their gut.
Why is this study important?
It aims to understand how surgeons decide whether to operate on babies with NEC, hoping to find ways to make better decisions and improve outcomes for these very sick babies.
Will my baby get extra treatments or tests as part of this study?
No, your baby will receive their usual medical care. The study only uses information that is already collected during their treatment.
Will my baby's information be kept private?
Yes, all personal details will be kept confidential and private, used only for research purposes.
Can I change my mind about taking part?
Yes, you can withdraw your consent at any time without it affecting your baby's medical care.
How to find out more
George S Bethell
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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