Oesophageal atresia is a rare condition, affecting around 150 babies every year in the UK, where babies are born without an intact oesophagus (swallowing tube). The condition normally requires urgent lifesaving surgery in the first days of life. The surgery is usually successful but children often go on to be affected by something called a 'stricture', where there is a narrowing in the oesophagus.
We want to answer the question:
“Should babies born with oesophageal atresia all be treated routinely with antacid medication to reduce strictures?”
To do this we are carrying out a two-phased study. Firstly, we looked at the feasibility of a running trial. We worked with doctors and families to explore what is important to them and whether they would be willing to take part in a trial. This first part of the study ran from March to November 2021 and is completed.
The findings from the feasibility study is now being used to design a multi-centre randomised controlled trial where babies born with oesophageal atresia are allocated at random to either being given antacid medication or not. For the main trial we plan to recruit over 200 infants from neonatal units across the UK. The main trial is planned to start in 2022 and run until August 2028.
TOAST is coordinated by the National Perinatal Epidemiology Unit Clinical Trial Unit (NPEU CTU) at the University of Oxford and is funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme.