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|Title:||Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux|
|Citation:||Journal of Pediatrics, 2003; 143(2):219-223|
|Moore, David John ; Tao, Billy Siang-Kuo ; Lines, David Robin ; Hirte, Craig ; Heddle, Margaret Lila ; Davidson, Geoffrey Paul|
|Abstract:||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. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period. RESULTS: The reflux index fell significantly during omeprazole treatment compared with placebo (-8.9%+/-5.6%, -1.9%+/-2.0%, P<.001). Cry/fuss time decreased from baseline (267+/-119), regardless of treatment sequence (period 1, 203+/-99, P<.04; period 2, 188+/-121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8+/-1.6, 4.8+/-2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo. CONCLUSIONS: Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.|
|Keywords:||Humans; Gastroesophageal Reflux; Esophagitis, Peptic; Omeprazole; Anti-Ulcer Agents; Cross-Over Studies; Double-Blind Method; Infant Behavior; Infant; Female; Male|
|Appears in Collections:||Paediatrics publications|
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