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TOAST – investigating the use of antacid medication for babies born with oesophageal atresia


Information for Parents

Oesophageal Atresia and Antacid Medication

Oesophageal atresia 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 done in the first few days of life. The surgery rebuilds the oesophagus. This is usually successful but sometimes there are problems. One of these problems is reflux, where the acid content of the stomach comes back into the oesophagus. Another problem that can happen is that the join, where the oesophagus has been rebuilt, can narrow down (called a stricture) and cause difficulties with feeding and swallowing. It is thought that strictures can be caused or made worse by reflux.

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, the evidence for using this medication to reduce the chance of getting a stricture is weak. We don't really know if it works. But we would like to find out because if it does then all babies with oesophageal atresia can be given this treatment and if it does not then we can stop asking parents to give medicine to their baby that has no benefit.

To find out whether or not giving an antacid medication is beneficial to treatment, we are conducting a two phased study. Firstly we conducted a feasibility study and now we are setting up a main trial, where infants with oesophageal atresia will be allocated at random to have an antacid medication or not.

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. So 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 OE, as well as 51 medical staff in this area. Overall, our findings indicated that trial is acceptable to parents and practitioners, and gave some recommendations for changes to the protocol, information materials and site training package. The final published paper can be found here:

Mixed-methods feasibility study to inform a randomised controlled trial of proton pump inhibitors to reduce strictures following neonatal surgery for oesophageal atresia

The TOAST Trial

As the feasibility study is now complete, and the main trial is being set up ready to recruit. As part of this some hospitals are being contacted to see if they would like to take part.

In this randomised controlled trial, babies with oesophageal atresia will be allocated at random to either being given acid suppressing medicine or not. They will then be followed up for 2 years, to see if they develop a stricture and require any further treatments.

If you have any questions about the study, you can contact the TOAST study team at the University of Oxford by emailing toast@npeu.ox.ac.uk.

Further Support

If you have any questions about the study, you can contact the TOAST study team at the University of Oxford by emailing toast@npeu.ox.ac.uk.

For further information and support about oesophageal atresia, 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 trial.

Updated: Wednesday, 04 December 2024 15:05 (v9)

For more information about TOAST, please view the contact details page