Acid suppression in infants has not been proven to be effective in reducing gastroesophageal reflux (GER) symptoms. In a systemic review, this was thought to be either “because the symptoms are not caused by GER or if due to GER, because the symptoms are caused by volume reflux, rather than acidity.” This quote is noted in the background information of another study which came to the same conclusion (J Pediatr 2013; 163: 692-8).
The pharmaceutical-supported study enrolled neonates (n=52) at 3 centers with gestational ages between 28-44 weeks. Half of the participants were randomized to esomeprazole (0.5 mg/kg/day) and half placebo. GER symptoms that were required for enrollment included any 2 of the following:
- apnea with or without bradycardia
- apnea with or without oxygen desaturations
Participants underwent extensive testing with video monitoring, esophageal pH & impedance testing, and cardiorespiratory monitoring. They were followed for 14 days.
- There were no significant differences in any GERD-related signs and symptoms.
- The esomeprazole group had improvement in acid reflux parameters on testing at 7 days, including number of reflux episodes (35 –>23) and mean percent time with pH<4.0. The latter change was -10.7% was statistically significant (p= .0017) compared to placebo group which had an increase in time with pH<4.0 (2.2% increase).
- No new safety signals were identified.
Despite its widespread usage, the authors had difficulty enrolling a larger cohort. The small sample size was one of the study’s limitations along with the 14-day study period. This limitation also precludes conclusions regarding the safety of these medications in neonates.
Bottomline: this study adds to the growing body of evidence that proton pump inhibitors (PPIs) are not effective in infants with so-called ‘signs and symptoms of reflux.’ PPIs are effective at reducing acid exposure and could be helpful in proven mucosal disease (eg. esophagitis and gastritis).
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