Omeprazole for Treatment of Term and preterm infants with gastro-oEsophageal Reflux (OTTER)
Gastro-oesophageal reflux
Eligible infants will be randomised in a 1:1 ratio to receive omeprazole or matched placebo after eligibility confirmation and parent/caregiver informed consent. Randomisation will be carried out by delegated site staff using REDCap, hosted by NCTU, and will be stratified within the preterm and term-born infant populations. A probabilistic minimisation algorithm will balance allocation by site, care setting, infant sex, feeding mode, and age or gestational age, as applicable. The trial is blinded, so parents/caregivers and recruiting site staff will not know the allocated treatment. Infants will receive either omeprazole oral suspension or matched placebo once daily for 28 days. Omeprazole dosing will be based on baseline or recent recorded weight, at 0.5 mL/kg once daily, equivalent to 1 mg/kg. The investigational medicinal product will be reconstituted by pharmacy and supplied ready to use, with inpatients receiving medication via the recruiting hospital pharmacy and outpatient/primary care participants receiving it by 24-hour home delivery from the central pharmacy.
Population 1 (Preterm infants): 1. Infants born <37 weeks’ gestation who are over 32 weeks corrected gestational age (8 weeks before their due date) and under 6 months past their due date at time of trial entry 2. Must be on full milk feeds at the time of eligibility assessment 3. Clinical diagnosis of symptomatic GOR made by a suitably qualified healthcare professional following clinical assessment 4. NICE guideline first-line interventions (including, but not limited to, feed thickeners and alginates) have either already been tried, or considered and are felt to be inappropriate by the treating clinician Population 2 (Term-born Infants): 1. Infants born ≥37 weeks’ gestation and who are under 6 months of age 2. Clinical diagnosis of symptomatic GOR made by a suitably qualified healthcare professional following clinical assessment 3. NICE guideline first-line interventions (including, but not limited to, feed thickeners and alginates) have either already been tried, or considered and are felt to be inappropriate by the treating clinician
1. Surgical conditions affecting feeding or the gastrointestinal tract, including but not limited to repaired oesophageal or intestinal atresia, congenital diaphragmatic hernia and gastroschisis/exomphalos 2. Progressive or severe neurological conditions affecting feeding 3. Infant has received any omeprazole or other proton-pump inhibitors in the preceding 2 weeks 4. Infant has known hypersensitivity to omeprazole or any of its excipients 5. Previous participation in the OTTER trial