TOAST - A multicentre, randomised trial of gastric acid suppression medication for treating oesophageal atresia to prevent stricture
Infants born with oesophageal artesia (OA) with distal-oesophageal fistula (TOF) who have undergone primary repair
Participants will be randomised using an online randomisation system to receive either esomeprazole (0.5mg/kg intravenously) once daily until infants are able to feed enterally followed by omeprazole (1mg/kg orally) once daily until 1 year of age, or a matched volume placebo given intravenously once daily until infants are able to feed enterally followed by matched volume placebo enteral administration, once daily until 1 year of age.
1. Infants (of any sex and any gestational age) with OA with distal TOF who have undergone ligation of the fistula and oesophageal anastomosis at the same time during the first operative intervention. 2. Infants have written informed consent obtained from an individual with parental responsibility. 3. Infants are expected to survive beyond the first year of life. 4. Infants within the end of day 3 after surgery where day of surgery is day 0. 5. Infants up to 2 weeks postnatal age. 6. In the opinion of a clinical member of the local research team (appropriately trained and experienced doctor or nurse), parents(s)/carer(s) of the infant are able and willing to comply with all study requirements, (including having a good understanding of the English language), or can be supported to do so (including the use of translation services).
1. Infants with OA without distal TOF 2. Infants who have undergone an operative intervention (e.g. emergency tracheo-oesophageal fistula ligation without anastomosis, initial gastrostomy) prior to the one where they underwent oesophageal anastomosis 3. Infants with any additional significant disorder or disease that, in the opinion of a clinical member of the research team, makes entry into the study inappropriate 4. Infants taking any medication that, in the opinion of a clinical member of the research team, makes entry into the study inappropriate