Treatment to prevent the narrowing of the oesophagus in a condition called oesophageal atresia (a disorder present at birth in which the oesophagus, the tube that carries food from the mouth to the stomach, does not develop properly)

Plain English summary of protocol

Background and study aims
Oesophageal atresia is a rare (about 1 in 2,500–3,000 births) condition where babies are born without an intact oesophagus (swallowing tube) and usually have a connection between their trachea (windpipe) and their stomach instead. It requires urgent lifesaving surgery in the first days of life. In the UK, every year around 150 babies are born with this condition
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 and can cause regurgitation of feeds and/or damage to the oesophagus. Another problem that happens sometimes 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.
Some surgeons who look after these babies use a medication to suppress the acid produced by the stomach even if there are no symptoms of reflux. A major reason for this is to reduce the risk of strictures forming. Despite this being an apparently popular option (about half of babies with oesophageal atresia are treated with this medication) the evidence for using this medication is weak. In fact, some studies of babies with oesophageal atresia have actually found that strictures are more common in babies treated with acid suppression than in those who were not. In addition, there is some suggestion that taking the medicine can increase the chance of certain types of infection.
We want to answer the question, “Should babies born with oesophageal atresia all be treated routinely with antacid medication to reduce strictures?”

Despite the common use of gastric acid suppression medication, we do not know for certain if there is any benefit to its use in babies following surgery. Indeed, some studies have indicated that babies routinely given gastric acid suppression medication may be more likely to get a stricture, but the evidence is not conclusive. There are other reasons why giving gastric acid suppression medication as a preventative measure (rather than as a treatment for children who are diagnosed with gastro-oesophageal reflux disease) may not be a good idea, including that it may slightly increase the risk of gastro-intestinal infections. Also, there are concerns about giving medicines to babies when there is no proven benefit.

Who can participate?
Babies with oesophageal atresia.

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

What are the possible benefits and risks of participating?
Benefits:
This study will not bring any immediate benefit to the participant.
Risks:
The treatments used in the study are used routinely for babies born with oesophageal atresia in UK hospitals and are known to be safe, so there are no extra risks involved from taking part in the study. The parent or carer will be asked to give trial medication/placebo once a day and record this on an app. We are asking the parents to record this once a day for the first week, but to reduce the burden, this is only once a week after the first month.
To further reduce the burden, we are only collecting data at routine visits that would occur as part of standard care following the surgery to repair the OA.
There are up to 7 questionnaires that the mother will be asked to complete. Links to these will be sent to them so they can complete at a convenient time or if they prefer they can complete on paper during their clinic visits.

Parents will be approached at a challenging and stressful time, soon after diagnosis of their child's OA. Due to this we have given 3 days to allow the parent(s) to be approached and then to think about taking part. If the child is diagnosed prior to birth, they will also be approached at this time to allow more time for their consideration. The person who approaches the parent about the trial will be someone from the direct clinical care team who are experts in OA and are sensitive to timings and so will know the appropriate way to approach them.

Any incidental findings that are identified during the course of the trial will be notified to the clinical team looking after the infant in question.

Where is the study run from?
National Perinatal Epidemiology Unit (NPEU), University of Oxford (UK)

When is the study starting and how long is it expected to run for?
May 2025 to October 2030

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Hayley Acton, toast@npeu.ox.ac.uk
Prof. Nigel Hall, n.j.hall@soton.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

University of Oxford
University/education

National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus
Oxford
OX3 7LF
United Kingdom

Phone	+44 1865 289278
Email	toast@npeu.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Editorial Notes

13/01/2023: Trial's existence confirmed by NHS HRA.