Every year, around 200 babies in the UK are born with oesophageal atresia—a gap in the food pipe that prevents them from swallowing—and surgeons routinely prescribe antacid drugs afterwards, despite no evidence that they help. This matters because the drugs are given to prevent a common complication: a narrowing (stricture) at the surgical join that can require repeated, invasive balloon dilatations. Current practice is based on belief, not data, and some evidence suggests antacids may actually cause harm, such as increasing infection risk. The TOAST trial will first test whether parents and clinicians find a placebo-controlled study acceptable, then randomise 200 infants to receive either antacid or placebo for a year after surgery. The primary outcome is the number of dilatations needed—a direct measure of stricture severity. If the trial shows antacids are no better than placebo, it could stop an unnecessary, potentially harmful routine treatment, saving the NHS money and sparing infants from side effects. If they do work, it would confirm a cheap, widely available intervention. Either way, the result will settle a decades-old clinical uncertainty and directly change neonatal surgical care.
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BACKGROUND: Babies born with oesophageal atresia (OA) are unable to feed unless they have a surgical intervention to join the two ends of the oesophagus. Following surgery, some surgeons prescribe prophylactic antacid medication believing that this will reduce the incidence of anastomotic stricture. There is no evidence to support this practice, indeed some evidence suggests it may be harmful. RESEARCH QUESTION: In infants born with oesophageal atresia (Population), does the routine use of antacid medication (Intervention) compared to matched placebo (Comparator) impact the incidence or severity of anastomotic stricture (Outcome)? AIMS AND OBJECTIVES: (1) To undertake a mixed-methods feasibility study with clinicians and parents to explore acceptability of the proposed trial including aspects of trial design, care pathways and outcomes (2) Incorporating lessons learnt from the feasibility study, to subsequently undertake a multicentre pragmatic blinded randomised controlled trial (RCT) with internal pilot and integrated economic evaluation TARGET POPULATION: Newborn infants with oesophageal atresia and distal tracheo-oesophageal fistula undergoing surgical repair. SETTING: Specialist NHS Neonatal Surgical Units in the UK. HEALTH TECHNOLOGY BEING ASSESSED: Infants enrolled will received either routine antacid medication or placebo from day of surgical repair for one year. MEASUREMENT OF COSTS AND OUTCOMES: The principal outcome measure of the feasibility phase will be acceptability of the trial protocol to parents and clinicians. Primary outcome for the RCT will be severity of stricture, defined as number of dilatations performed within 1 year of trial entry. Secondary outcomes (measured at timepoints up to 1 year) include incidence of stricture, and other directly related procedures, adverse events, presence of symptoms of gastro-oesophageal reflux, need for treatment of reflux, growth, oral intake, respiratory symptoms, episodes of infection, maternal quality of life and mortality. Integrated within the trial we will conduct an economic evaluation from an NHS and societal perspective. SAMPLE SIZE: 200 infants for the RCT would have 90% power to detect an increase of at least 2.7 in the odds of reducing the number of dilatations per infant within 1 year of trial entry by one at 5% two-sided level of statistical significance. PROJECT TIMETABLES AND RECRUITMENT RATE: Total duration 90 months: 9-month feasibility phase, followed by a 3-month period to finalise trial delivery plan. Internal RCT pilot will take place at all recruiting centres for 18 months. Total recruitment period: 60 months, with 12 months follow-up, followed by final analysis and dissemination (6 months). EXPERTISE IN TEAM: The team has extensive experience in the design and conduct of RCTs in surgery and in newborn infants, trial methodology, surgical expertise, statistical and health economic analysis, qualitative methods, feasibility studies involving children. The study is supported by a specialist perinatal CTU and has strong PPI involvement. Indeed, PPI have suggested the choice of primary outcome and perceive the study as a potential milestone in care of oesophageal atresia patients. IMPACT AND DISSEMINATION: This trial will provide conclusive evidence concerning the efficacy of antacid medication at reducing incidence and severity of stricture following oesophageal atresia repair. We will disseminate via scientific and lay channels to maximise impact.
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