Gastro-oesophageal reflux Digestive System
Conditions
Interventions
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
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Days to 6 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of gastro-oesophageal reflux symptoms measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R), 12-item caregiver-completed questionnaire at 4 weeks after randomisation (end of intervention period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. GOR symptom severity measured using Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) at 2 weeks 2. Treatment escalation measured using parent or caregiver questionnaires and medical note review at 4 weeks and/or 6 months 3. Oesophagitis measured using medical note review at 4 weeks and/or 6 months 4. Haematemesis measured using parent or caregiver questionnaires and medical note review at 4 weeks and/or 6 months 5. Further GOR medication use measured using parent or caregiver questionnaires and medical note review at 4 weeks and/or 6 months 6. Hospital admissions measured using parent or caregiver questionnaires and medical note review at 4 weeks and/or 6 months 7. Length of hospital stay measured using medical note review at 4 weeks and/or 6 months 8. Crying or fussing measured using relevant IQI items at up to 6 months 9. Feeding difficulties measured using relevant IQI items at up to 6 months 10. Sleep quality measured using relevant IQI items at up to 6 months 11. Infant health-related quality of life measured using relevant IQI items at up to 6 months 12. Growth measured using change in weight standard deviation score at up to 6 months 13. Necrotising enterocolitis measured using medical note review at up to 6 months 14. Bacterial infections measured using parent or caregiver questionnaires and medical note review at up to 6 months 15. Gastrointestinal infections measured using parent or caregiver questionnaires and medical note review at up to 6 months 16. Respiratory infections measured using parent or caregiver questionnaires and medical note review at up to 6 months 17. Fractures measured using medical note review at up to 6 months 18. Healthcare use measured using parent or caregiver questionnaires and medical note review at up to 6 months 19. Parental health-related quality of life measured using EQ-5D-5L at up to 6 months 20. Parent experiences of the trial and treatment measured using semi-structured interviews during follow-up 21. Hea | — |
Countries
England, United Kingdom
Contacts
Public Contact- OTTER Trial Team
Outcome results
None listed