Omeprazole for Treatment of Term and preterm infants with gastro-oEsophageal Reflux (OTTER)

University Hospital Southampton NHS Foundation Trust0 个研究点目标入组 500 人开始时间: 2026年7月30日最近更新: 2026年8月10日

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•Population 1 (Preterm infants):
•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
•Must be on full milk feeds at the time of eligibility assessment
•Clinical diagnosis of symptomatic GOR made by a suitably qualified healthcare professional following clinical assessment
•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):
•Infants born =37 weeks’ gestation and who are under 6 months of age
•Clinical diagnosis of symptomatic GOR made by a suitably qualified healthcare professional following clinical assessment
•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

•Surgical conditions affecting feeding or the gastrointestinal tract, including but not limited to repaired oesophageal or intestinal atresia, congenital diaphragmatic hernia and gastroschisis/exomphalos
•Progressive or severe neurological conditions affecting feeding
•Infant has received any omeprazole or other proton-pump inhibitors in the preceding 2 weeks
•Infant has known hypersensitivity to omeprazole or any of its excipients
•Previous participation in the OTTER trial

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