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Type: Journal article
Title: Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients
Author: Davidson, G.
Wenzl, T.
Thomson, M.
Omari, T.
Barker, P.
Lundborg, P.
Illueca, M.
Citation: Journal of Pediatrics, 2013; 163(3):692-698
Publisher: Mosby Inc
Issue Date: 2013
ISSN: 0022-3476
Statement of
Geoffrey Davidson, Tobias G. Wenzl, Michael Thomson, Taher Omari, Peter Barker, Per Lundborg, and Marta Illueca
Abstract: <h4>Objective</h4>To evaluate the efficacy and safety of proton pump inhibitors in infants aged <1 year with gastroesophageal reflux disease (GERD).<h4>Study design</h4>In this randomized, double-blind, placebo-controlled multicenter study, neonates (premature to 1 month corrected age; n = 52) with signs and symptoms of GERD received esomeprazole 0.5 mg/kg or placebo once daily for up to 14 days. Change from baseline in the total number of GERD symptoms (from video monitoring) and GERD-related signs (from cardiorespiratory monitoring) was assessed with simultaneous esophageal pH, impedance, cardiorespiratory, and 8-hour video monitoring.<h4>Results</h4>There were no significant differences between the esomeprazole and placebo groups in the percentage change from baseline in the total number of GERD-related signs and symptoms (-14.7% vs -14.1%, respectively). Mean change from baseline in total number of reflux episodes was not significantly different between esomeprazole and placebo (-7.43 vs -0.2, respectively); however, the percentage of time pH was <4.0 and the number of acidic reflux episodes >5 minutes in duration was significantly decreased with esomeprazole vs placebo (-10.7 vs 2.2 and -5.5 vs 1.0, respectively; P ≤ .0017). The number of patients with adverse events was similar between treatment groups.<h4>Conclusions</h4>Signs and symptoms of GERD traditionally attributed to acidic reflux in neonates were not significantly altered by esomeprazole treatment. Esomeprazole was well tolerated and reduced esophageal acid exposure and the number of acidic reflux events in neonates.
Keywords: Humans
Gastroesophageal Reflux
Infant, Premature, Diseases
Monitoring, Physiologic
Treatment Outcome
Administration, Oral
Drug Administration Schedule
Analysis of Variance
Follow-Up Studies
Double-Blind Method
Infant, Newborn
Infant, Premature
Proton Pump Inhibitors
Intention to Treat Analysis
Rights: Copyright © 2013 Mosby, Inc. All rights reserved.
DOI: 10.1016/j.jpeds.2013.05.007
Appears in Collections:Aurora harvest 4
Paediatrics publications

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