Omeprazole for gastroesophageal reflux disease in the first 2 years of life: a dose-finding study with dual-channel pH monitoring.

BACKGROUND AND AIM: 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.

PATIENTS AND METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.