Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux.

Objective: To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.

Study Design: Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole.