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 planning a two phased study. Firstly we will conduct a feasibility study and then we will run 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 before we conduct the trial we are conducting a feasibility study to understand the views of parents and doctors, in order to find out whether a clinical trial is acceptable to them.
To help us to find out what parents think about the trial and to help design it, we will interview about 25 parents with infants born with oesophageal atresia. By speaking to parents we hope to find out whether the trial is acceptable and, if so, how it should be done. It will also help us to be able to ensure that what we are proposing is as parent and patient centred as possible.
If you have any questions about the study, you can contact the TOAST study team at the University of Oxford by emailing email@example.com.
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.