Infants born with oesophageal artesia (OA) with distal-oesophageal fistula (TOF) who have undergone primary repair Digestive System
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of anastomotic stricture is defined as number of oesophageal dilatations from randomisation up to one year of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity and incidence of anastomotic stricture during the first 2 years of life is measured by number of oesophageal dilatations up to 2 years of age. 2. Severity and incidence of anastomotic stricture during the first 2 years of life is measured by incidence of anastomotic stricture (one or more dilatations) up to 1 and 2 years of age. 3. Severity and incidence of anastomotic stricture during the first 2 years of life is measured by histological diagnosis of oesophagitis. 4. The influence of routine gastric suppression medication versus matched placebo is measured by all-cause mortality up to 1 year and 2 years of age. 5. The influence of routine gastric suppression medication versus matched placebo is measured by mortality directly related to OA up to 1 year and 2 years of age. 6. The influence of routine gastric suppression medication versus matched placebo is measured by any anastomotic complications (i.e., anastomotic leak, recurrent fistula) up to 1 year and 2 years of age. 7. The influence of routine gastric suppression medication versus matched placebo is measured by number of procedures performed under general anaesthetic (GA) related to OA up to 1 year and 2 years of age. 8. The influence of routine gastric suppression medication versus matched placebo is measured by number of serious adverse reactions up to 1 year of age. 9. The influence of routine gastric suppression medication versus matched placebo is measured by any non-GA diagnostic study related to OA, and findings, up to 1 year and 2 years of age 10. The influence of routine gastric suppression medication versus matched placebo is measured by duration of dose of any gastric acid suppression medication given in addition to study medication up to 1 year of age 11. The influence of routine gastric suppression medication versus matched placebo is measured by max level of intervention (based on the treatment flow diagram) reached for treatment of reflux symptoms in preceding 3 months (described usi | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed