Omeprazole for Gastroesophageal Reflux Disease in the First 2 Years of Life: A Dose‐finding Study With Dual‐channel pH Monitoring

Abstract

Gastroesophageal reflux occurs in the majority of infants, with severity ranging from asymptomatic to severe esophagitis and failure to thrive. Omeprazole is recognized as a safe and effective treatment of gastroesophageal reflux in older children, at an initial dosage of 0.7 mg x kg(-1) x day(-1). To our knowledge, no dose-finding studies have been carried out in children under 2 years of age. The aim of the present study was to prospectively determine the dosage of omeprazole required to treat symptomatic gastroesophageal reflux in children younger than 2 years. Children under 2 years with clinical suspicion of gastroesophageal reflux underwent 24-hour dual-channel intraesophageal/gastric pH monitoring. A reflux index above 10% in children under 1 year and above 6% in children older than 1 year was deemed significant. Treatment with omeprazole at an initial dosage of 0.7 mg x kg(-1) x day(-1) (in 2 divided doses) was followed by dual-channel pH study after 14 days. The dosage was increased in increments of 0.7 mg x kg(-1) x day(-1), and pH studies were repeated until the gastroesophageal reflux was controlled. Ten children (5 male, 5 female), mean age 7.75 months (range, 1.25-20 months), were investigated. The initial median reflux index was 18.5% (range, 6.5%-56.3%). Follow-up median reflux index was improved at 1.6% (0.1%-8.1%) (P < 0.05). The median dosage required was 1.05 mg x kg(-1) x day(-1). Four children required 1.4 mg x kg(-1) x day(-1), and 1 required 2.8 mg x kg(-1) x day(-1). Corrected reflux index improved from 34.8% (16.8%-90.8%) to 20.1% (0.4%-100%) but did not achieve statistical significance. There were no serious complications or side effects. Omeprazole is an effective treatment for gastroesophageal reflux in children younger than 2 years. The majority respond to a dosage of 0.7 mg x kg(-1) x day(-1), but increased dosages up to 2.8 mg x kg(-1) x day(-1) may be required.