Researchers from NDPH’s National Perinatal Epidemiology Unit (NPEU) are helping to coordinate a new large-scale study that will investigate whether antacid medications help or hinder treatment of babies born with oesophageal atresia (OA), a severe birth defect.
OA occurs when part of the baby’s oesophagus (or ‘feeding tube’) does not form correctly, meaning it is not connected to the stomach. Although it is very rare, it requires surgery within the first few days of life to join the upper and lower parts of the oesophagus. Up to half of affected infants will later develop a narrowing (or 'stricture’) at the introduced join. This usually requires at least one more invasive procedure to correct.
Some surgeons routinely prescribe antacids (medications that neutralise stomach acid) to children born with OA. There is a popular belief that antacids may reduce the chance of a stricture occurring, or reduce its severity, however there is currently no evidence that antacids are beneficial. In fact, there is some evidence to suggest that antacids may actually increase the chance of a stricture occurring, and also the risk of certain types of infection.
This new study, called Treating Oesophageal Atresia to prevent STricture (TOAST), will compare two groups of children born with OA. One group will be given antacids routinely and the other will receive a placebo medication instead. The research team will compare how many children in each group develop a stricture and how many procedures to treat the stricture each child needs. They will also evaluate other important outcomes for these children, such as growth. The team believe this is the first large-scale trial to be done in the world specifically on OA. The feasibility phase of the trial will run from March - November 2021, working with doctors and families to explore what is important to them and whether they would be willing to take part.
Associate Professor Nigel Hall, Consultant Paediatric Surgeon and co-Chief Investigator from the University of Southampton said ‘If antacid treatment is beneficial, then we can justifiably give it to all babies during their early lives knowing that it is doing some good. If, however, we find that it is not beneficial then we can avoid asking parents to give this medicine to their children and we can reduce the potential side effects from unnecessarily taking this medication.’
The trial is expected to be large, and last for several years, with most babies with OA who have been operated upon in the UK offered the opportunity to participate.
The National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU), which specialises in trials and research into pregnancy and babies, will run and deliver all aspects of the trial, from helping to manage and coordinate the research to working with parents to obtain their views on the trial.
Associate Professor Charles Roehr of the NPEU CTU said: ‘Evidence of effectiveness for any medical therapy needs to be based on robust science. This includes prescribing antacid treatment for babies with oesophageal atresia. Only a large-scale, randomised clinical trial such as this one can generate the evidence needed to determine whether antacid treatments help these babies.’
The study is funded by a grant from the National Institute for Health Research (NIHR) and also involves researchers at the University of Southampton, Evelina Children's Hospital, London and the University of Liverpool. It is supported by Tracheo-Oesophageal Fistula Support (TOFS), the support group for people born with OA and their families.
Mr John Pearce, a representative of TOFS and part of the study team, said ‘We expect that this study will, in time, lead to a real step forward in knowing how best to treat OA babies. We are delighted to be supporting this study and offer children born with OA and their families the opportunity to take part in this important research’.