Published randomised controlled trials (RCTs) that evaluated proton pump inhibitors with any dosage regime in the treatment of infants (age two years or less) diagnosed with gastro-oesophageal reflux (however defined) were eligible for inclusion if the control group received a placebo or no treatment. The included studies were of preterm infants (34 to 40 weeks postmenstrual age) and infants aged three to 12 months with a reflux index (RI) of more than 5% (reflux index is percentage of time during which the oesophageal acid pH is less than 4) or with oesophagitis measured by biopsy.
Intervention groups for the included studies used either 0.7mg/kg omeprazole in 2mL/kg antacid solution given by a nasogastric tube for seven days or 10mg omeprazole (once or twice daily depending on weight) for two weeks. Control groups used either a placebo or sterile water. The primary eligible outcomes were: symptoms or change in symptoms of gastro-oesophageal reflux (such as regurgitation, crying, irritability, vomiting, gagging) assessed subjectively by the parent/guardian and/or the treating physician; adverse events; occurrence of any clinical complications of gastro-oesophageal reflux (such as respiratory symptoms); and weight gain. Secondary eligible outcomes that related to reflux index reported in the included studies included: number of episodes of pH less than 4; number of episodes of pH less than 4 lasting more than five minutes; and duration of longest episode of pH less than 4. Eligible studies had to report at least one primary outcome.
Two researchers independently screened potentially relevant articles.