All studies
RecruitingPhase IIIInterventional

Treatment to prevent the narrowing of the oesophagus in a condition called oesophageal atresia (a disorder present at birth in which the oesophagus, the tube that carries food from the mouth to the stomach, does not develop properly)

This study is for babies born with a rare condition called oesophageal atresia (OA), where their food pipe isn't fully formed. After surgery to fix this, some babies are given medication to reduce stomach acid, hoping to prevent the food pipe from narrowing. However, we don't fully understand if this medicine truly helps or if it might cause other issues, such as increasing the risk of infections. This research aims to answer that question by comparing babies who receive the medicine with those who don't. By understanding this better, doctors can make more informed decisions about the best care for these babies and potentially avoid unnecessary medications.

At a glance

Status
Recruiting
Phase
Phase III
Sponsor
University of Oxford
Enrolment target
211
Start
01 Nov 2025
Estimated completion
31 Oct 2030

What is this study about?

When babies are born with oesophageal atresia, their food pipe (the tube that carries food to the stomach) isn't properly connected. They need urgent surgery soon after birth to fix this. While the surgery is often successful, sometimes problems can still occur. One common issue is that the food pipe might narrow where it was joined, making feeding and swallowing difficult. It’s thought that stomach acid coming back up (reflux) can contribute to this narrowing.

Many doctors often give babies medicine to reduce stomach acid after this surgery, believing it might prevent the food pipe from narrowing. However, we're not sure if this medicine actually helps. Some studies have even suggested that babies given this medicine might be *more* likely to experience narrowing, and there's a small chance it could increase the risk of certain infections. Because of these uncertainties, doctors want to find out for sure if giving this medicine routinely is beneficial.

This study aims to discover whether giving acid-reducing medicine to *all* babies after oesophageal atresia surgery is truly helpful in preventing the food pipe from narrowing, or if it might be better not to use it unless there are clear symptoms of reflux. The findings will help doctors provide the best and safest care for babies with oesophageal atresia.

Key takeaways

  • It's about babies born with a rare condition affecting their food pipe.
  • Investigating if a common stomach acid medicine really helps prevent complications after surgery.
  • Babies are randomly assigned to receive the medicine or not.
  • No new risks, as medicines are routinely used.
  • Study aims to improve future care for babies with oesophageal atresia.
  • Participation involves giving medicine/placebo and reporting via an app.

Who may be eligible?

This study is looking for babies who were born with a specific type of oesophageal atresia (OA) where there's a connection between their food pipe and windpipe (called a distal-oesophageal fistula). They must have had surgery to fix this problem and join their food pipe properly.

Babies can join the study if they are under two weeks old and within the first three days after their surgery. We also need to be sure that the baby is expected to live beyond their first year, and that their parents or carers can understand and follow the study instructions – some help, like translation services, can be provided.

Babies cannot join if they have other serious health problems that would make taking part unsafe, or if they are already taking medicines that would interfere with the study. Also, if their OA didn't involve the specific connection mentioned above, or if they had other operations related to their OA before the main repair, they wouldn't be eligible.

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.

  1. Was your baby born with oesophageal atresia (OA) with a connection to the windpipe?
  2. Has your baby had surgery to fix their food pipe?
  3. Is your baby less than two weeks old?
  4. Is it within three days since your baby's surgery?
  5. Are you able and willing to follow study instructions, potentially with support?
  6. Does your baby not have other serious health issues that would prevent participation?
Answer every question to see your result.

What does participation involve?

If your baby takes part, they will be randomly chosen (like flipping a coin) to either receive the acid-reducing medicine or not. This is a common way to ensure the study is fair. You will be asked to give your baby the study medicine (or a dummy medicine, called a placebo) once a day for the first week, and then once a week after the first month. You'll record this in a special app.

To make it as easy as possible for you, we will only collect information during the regular check-up appointments your baby would have anyway after their surgery. You will also be asked to complete up to seven short online questionnaires at home, or on paper during clinic visits if you prefer. The study will follow your baby for about two years to see if they develop any narrowing of the food pipe and if they need any extra treatments.

Potential risks and benefits

There are no immediate health benefits to your baby from taking part in this specific study, though the information we learn will help future babies with this condition. The medicines used in the study are already routinely given to babies in UK hospitals and are considered safe, so participating doesn't add any extra risks to your baby’s care. Your family will have the support of the expert team. You are completely free to withdraw your baby from the study at any time, for any reason, and this will not affect their medical care.

Locations (15)

  • University Hospital Southampton
    City only
    Southampton, United Kingdom
  • Evelina London Children’s Hospital
    Approximate
    London, United Kingdom
  • Alder Hey Children’s Hospital
    Approximate
    Liverpool, United Kingdom
  • Royal Hospital for Sick Children (Glasgow)
    Approximate
    Glasgow, United Kingdom
  • Royal Manchester Children's Hospital
    Approximate
    Manchester, United Kingdom
  • John Radcliffe Hospital
    Unverified
    Oxford, United Kingdom
  • University Hospital of Wales
    Unverified
    Cardiff, United Kingdom
  • Royal Hospital for Children and Young People
    Unverified
    Lothian, United Kingdom
  • St George's Hospital
    Unverified
    London, United Kingdom
  • Bristol Royal Hospital for Sick Children
    Unverified
    Bristol, United Kingdom
  • Birmingham Children’s Hospital
    Unverified
    Birmingham, United Kingdom
  • Royal Victoria Infirmary
    Unverified
    Newcastle upon Tyne, United Kingdom

Common questions

What is oesophageal atresia?

It's a rare condition where a baby's food pipe (oesophagus) doesn't fully form or connect properly, requiring surgery soon after birth.

What is the main problem this study is trying to solve?

The study wants to find out if giving acid-reducing medicine to babies after oesophageal atresia surgery truly prevents the food pipe from narrowing.

Will my baby definitely get the medicine if we join?

No. Your baby will be randomly assigned to either receive the medicine or not, so we can fairly compare the two groups.

How long will my baby be part of the study?

Your baby will be followed for about two years after their surgery.

Can I change my mind after joining?

Yes, you can withdraw your baby from the study at any time, and it won't affect their medical care.

How to find out more

Hayley Acton

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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