Information for Parents
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Oesophageal Atresia and Antacid Medication
Oesophageal atresia (OA) is a rare condition where babies are born without an intact oesophagus (swallowing tube) and usually have a connection between their windpipe and their stomach instead.
Urgent lifesaving surgery is usually performed in the first few days of life to rebuild the oesophagus and enable feeding. This is usually successful but sometimes there are problems. The region where the oesophagus has been rebuilt, can become narrow (called a stricture) and this can cause difficulties with feeding and swallowing. It is thought that strictures can be caused or made worse by acid reflux from the stomach travelling up the oesophagus to the rebuilt region.
Antacid medication is sometimes used to suppress the acid produced by the stomach and help reduce the risk of strictures. Despite this treatment being used in about half of babies with oesophageal atresia, there is little evidence to show whether this medication actually helps to reduce the chance of getting a stricture. We don't really know if it works, but we would like to find out. If we learn from this trial that the antacid medication does help, then we can recommend that all babies with OA are given the treatment. If we find that the antacid medication does not make a difference, then we can stop asking parents to give medicine to their baby that has no benefit.
To find out whether or not giving antacid medication to OA babies is beneficial, we are conducting a two phased study – a feasibility study, followed by the main trial.
The Feasibility Study
The ideal way to study whether giving antacid medication benefits treatment or not is to conduct a clinical trial; randomly allocating babies to receive antacid medication or not, to see how it affects the likelihood of developing strictures and their severity. However, a clinical trial like this may or may not be acceptable to parents or health professionals. A feasibility study was conducted in 2021 to understand the views of parents and doctors, in order to find out whether a clinical trial would be acceptable to them.
We interviewed 18 parents of infants born with OA, as well as 51 medical staff in this area. Overall, our findings indicated that the trial is acceptable to parents and practitioners, and they gave some recommendations for changes to the protocol, information materials and site training package, which we have incorporated into the main trial design. The final published paper can be found here:
The TOAST Study
Once the feasibility study was completed, the main trial was designed and approved by the clinical trial regulatory bodies in the UK, under the sponsorship of University of Oxford. We are now ready to start recruitment, and are currently contacting UK hospitals to see if they would like to take part in TOAST Study.
TOAST Study is a randomised controlled trial, in which babies with oesophageal atresia will be allocated at random to either being given daily acid suppressing medicine or not, until 1 year of age. They will then be followed up for 2 years, to see if they develop a stricture and require any further treatments.
Further Support
If you have any questions about TOAST Study, please talk to the local research team at your hospital, or you can contact the TOAST Study team at NPEU CTU by emailing toast@npeu.ox.ac.uk.
For further information and support about oesophageal atresia (OA), please visit the TOFS website. TOFS is a specialist charity and UK support group dedicated to improving the lives of all those born with oesophageal atresia. TOFS is our charitable partner on the TOAST Study.
