Primary Posterior Tracheopexy Prevents Tracheal Collapse
Many babies born with a condition where their food pipe isn't fully formed (oesophageal atresia) also have a floppy windpipe that can collapse (tracheomalacia). This causes breathing difficulties and infections. Currently, doctors might wait and see if it gets better, or perform a bigger surgery later. This study is testing if doing a small extra surgery, called a primary posterior tracheopexy, at the same time as their first operation can prevent these problems. Doctors will compare babies who have this extra step to those who don't, to see if it helps keep their windpipe strong and open from the start.
At a glance
What is this study about?
When a baby is born with a condition called oesophageal atresia, it means their food pipe (oesophagus) isn't fully formed. They need an operation, usually in their first week of life, to fix this. It's quite common for these babies to also have a floppy windpipe (trachea), a condition called tracheomalacia. This can cause the windpipe to partially collapse when they breathe out, leading to breathing problems like frequent chest infections, blue spells, and sometimes even life-threatening events.
Currently, if a baby develops severe tracheomalacia symptoms, they might need another bigger operation later on to strengthen their windpipe. This second operation involves using stitches to widen the windpipe and prevent it from collapsing. However, by the time this second surgery happens, the baby might have already suffered from breathing difficulties and complications. Also, performing this surgery separately can be more complicated and risky because of the previous operation.
Doctors are now exploring whether adding a small step to the baby's very first operation for oesophageal atresia can prevent these problems. This extra step, called a primary posterior tracheopexy (PPT), is a way to strengthen the windpipe early on. This study aims to find out if performing this PPT at the same time as the initial surgery helps reduce or prevent the windpipe from collapsing, compared to the current approach of waiting to see if symptoms develop.
Key takeaways
- The study investigates a new approach to prevent windpipe collapse in babies.
- It compares a new surgical step during first surgery to the standard approach.
- The aim is to reduce breathing problems and future surgeries.
- Participation involves routine checks of the windpipe with a small camera.
- Both treatment options are considered safe and accepted.
- The study is 'double-blind,' meaning no one involved knows the treatment group.
Who may be eligible?
This study is looking for newborn babies who have been diagnosed with a specific type of oesophageal atresia, where their food pipe is not fully formed and there's also a connection to their windpipe. They must also have a floppy windpipe condition called tracheomalacia.
To join, both parents or legal guardians must give their written permission and understand what being part of the study involves. Babies will not be included if their food pipe condition is different, if they were born very early (before 34 weeks), or if they have certain other medical conditions. They also need to be able to safely have a small tube placed in their windpipe for examination and have a windpipe size that allows for this.
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 diagnosed with oesophageal atresia with a connection to the windpipe?
- Does my baby also have a floppy windpipe (tracheomalacia)?
- Was my baby born at 34 weeks or later?
- Are we, as parents, able to provide written permission?
- Does my baby have any other major heart problems or conditions that might exclude them?
What does participation involve?
If your baby takes part in this study, they will be randomly assigned to one of two groups: either they will receive the new strengthening procedure on their windpipe during their first surgery, or they will have the standard surgery without this extra step. Doctors won't know which group your baby is in. They will look at your baby's windpipe using a small camera (called a tracheobronchoscopy) before, during, and twice after the surgery – once during recovery and again a few months later. These examinations are already a routine part of care for these babies. You'll also have three routine check-up appointments until your baby is six months old, where doctors will check for any breathing issues. The total time your baby is actively followed for the study is about six months.
Potential risks and benefits
Locations (3)
- Erasmus Medical Center RotterdamVerified postcodeRotterdam, Netherlands
- University Medical Center UtrechtVerified postcodeUtrecht, Netherlands
- Great Ormond Street HospitalVerified postcodeLondon, United Kingdom
Common questions
What is oesophageal atresia?
It's a birth defect where a baby's food pipe (oesophagus) isn't fully formed, usually requiring surgery soon after birth.
What is tracheomalacia?
It's when a baby's windpipe (trachea) is floppy and can partly collapse when they breathe out, causing breathing problems.
What is Primary Posterior Tracheopexy (PPT)?
It's a small extra surgery performed during the initial operation for oesophageal atresia to help strengthen the windpipe and prevent it from collapsing.
Will my baby's doctor know which treatment group they are in?
No, this is a 'double-blind' study, meaning neither you, your baby's doctors, nor the study team will know which group your baby is assigned to until the study ends.
Are there extra appointments for the study?
Some procedures, like checking your baby's windpipe with a camera, are already routine. You will also have three standard follow-up appointments until your baby is six months old.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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