TOAST
Oesophageal atresia (OA) 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 requires urgent lifesaving surgery in the first days of life to enable the baby to feed. The surgery is usually successful but babies often go on to develop a 'stricture', - a narrowing of the rebuilt region of the oesophagus - which requires a mechanical stretching procedure called a 'dilatation' under general anaesthetic to resolve. OA babies can develop multiple strictures during their first year of life, and some clinicians believe that acid reflux from the stomach may increase the chances of these strictures developing, so they prescribe antacid medication post-surgery as a preventative measure. Not all clinicians prescribe this medication post-surgery for OA, and it is currently unclear whether it is beneficial to do so.
To learn more about TOAST Study, please watch our TOAST Trial Overview video.
We want to answer the question:
“Should all babies born with oesophageal atresia 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 running a 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 was completed from March to November 2021.
The findings from this feasibility study have now used to design a multicentre double-blind, randomised placebo-controlled trial where babies born with oesophageal atresia are allocated at random to either being given daily antacid medication or not until 1 year of age. We plan to recruit 211 babies from neonatal surgical units across the UK. Recruitment will start in January 2026 and run for 60 months, until the end of December 2031.
TOAST is co-ordinated by the National Perinatal Epidemiology Unit Clinical Trial Unit (NPEU CTU) at the University of Oxford and is funded by the National Institutefor Health and Care Research (NIHR) Health Technology Assessment (HTA) programme.
TOFS is a charity providing support to families affected by oesophageal atresia and tracheo-oesophageal fistula. TOFS is a patient and public involvement (PPI) partner for the study. The link above shows a video produced by TOFS with some further background on these conditions.
The link above shows a video recording of a presentation given by Professor Nigel Hall (TOAST Chief Investigator) regarding the TOAST trial at the TOFS Seminar in November 2023.
