Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux.
BACKGROUND
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.
Omari
Taher I
TI
Department of Paediatrics, University of Adelaide, Australia. taher.omari@adelaide.edu.au
Haslam
Ross R
RR
Lundborg
Per
P
Davidson
Geoffrey P
GP
D000897:Anti-Ulcer Agents / Q000494:pharmacology / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D050782:Esophageal pH Monitoring; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D009853:Omeprazole / Q000494:pharmacology / Q000627:therapeutic use; D054328:Proton Pump Inhibitors
D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D009853:Omeprazole