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https://hdl.handle.net/2440/7614
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Type: | Journal article |
Title: | Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux |
Author: | Moore, D. Tao, B. Lines, D. Hirte, C. Heddle, M. Davidson, G. |
Citation: | Journal of Pediatrics, 2003; 143(2):219-223 |
Publisher: | Mosby Inc |
Issue Date: | 2003 |
ISSN: | 0022-3476 1097-6833 |
Statement of Responsibility: | Moore, David John ; Tao, Billy Siang-Kuo ; Lines, David Robin ; Hirte, Craig ; Heddle, Margaret Lila ; Davidson, Geoffrey Paul |
Abstract: | <h4>Objective</h4>To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.<h4>Study design</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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 |
DOI: | 10.1067/S0022-3476(03)00207-5 |
Published version: | http://dx.doi.org/10.1067/s0022-3476(03)00207-5 |
Appears in Collections: | Aurora harvest Paediatrics publications |
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