INTRODUCTION:Proton pumpinhibitor (PPI) therapy is increasingly being used to treat premature infants with gastroesophageal reflux disease (GERD); however, the efficacy of PPI on acid production in this population has yet to be assessed in this patient group. The aim of this study was to determine the effect of 0.7 mg/kg/d omeprazole on gastric acidity and acid gastroesophageal reflux in preterm infants with reflux symptoms and pathological acid reflux on 24-h pH probe. METHODS: A randomized, double blind, placebo-controlled, crossover design trial of omeprazole therapy was performed in 10 preterm infants (34-40 weeks postmenstrual age). Infants were given omeprazole for 7 d and then placebo for 7 d in randomized order. Twenty-four-hour esophageal and gastric pH monitoring was performed on days 7 and 14 of the trial. RESULTS: Compared to placebo, omeprazole therapy significantly reduced gastric acidity (%time pH <4, 54% vs 14%, P < 0.0005), esophageal acid exposure (%time pH <4, 19% vs 5%, P < 0.01) and number of acid GER episodes (119 vs 60 episodes, P < 0.05). CONCLUSIONS:Omeprazole is effective in reducing esophageal acid exposure in premature infants with pathological acid reflux on 24-h pH probe; however, the far more complex issues of safety and efficacy have yet to be addressed.
RCT Entities:
INTRODUCTION:Proton pump inhibitor (PPI) therapy is increasingly being used to treat premature infants with gastroesophageal reflux disease (GERD); however, the efficacy of PPI on acid production in this population has yet to be assessed in this patient group. The aim of this study was to determine the effect of 0.7 mg/kg/d omeprazole on gastric acidity and acid gastroesophageal reflux in preterm infants with reflux symptoms and pathological acid reflux on 24-h pH probe. METHODS: A randomized, double blind, placebo-controlled, crossover design trial of omeprazole therapy was performed in 10 preterm infants (34-40 weeks postmenstrual age). Infants were given omeprazole for 7 d and then placebo for 7 d in randomized order. Twenty-four-hour esophageal and gastric pH monitoring was performed on days 7 and 14 of the trial. RESULTS: Compared to placebo, omeprazole therapy significantly reduced gastric acidity (%time pH <4, 54% vs 14%, P < 0.0005), esophageal acid exposure (%time pH <4, 19% vs 5%, P < 0.01) and number of acid GER episodes (119 vs 60 episodes, P < 0.05). CONCLUSIONS:Omeprazole is effective in reducing esophageal acid exposure in premature infants with pathological acid reflux on 24-h pH probe; however, the far more complex issues of safety and efficacy have yet to be addressed.
Authors: Jaroslaw Kierkus; Wanda Furmaga-Jablonska; Janice E Sullivan; Elmer S David; Dan L Stewart; Natalie Rath; Caifeng Fu; Wenjin Wang; Mary K Maguire; Gail M Comer Journal: Dig Dis Sci Date: 2010-07-07 Impact factor: 3.199
Authors: Catherine A Golski; Ellen S Rome; Richard J Martin; Scott H Frank; Sarah Worley; Zhiyuan Sun; Anna Maria Hibbs Journal: Pediatrics Date: 2009-12-14 Impact factor: 7.124
Authors: Jaroslaw Kierkus; Grzegorz Oracz; Bartosz Korczowski; Edyta Szymanska; Anna Wiernicka; Marek Woynarowski Journal: Drug Saf Date: 2014-05 Impact factor: 5.606
Authors: Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Nello Martini; Luciano Sagliocca; Giuseppe Traversa Journal: Eur J Clin Pharmacol Date: 2008-09-17 Impact factor: 2.953