Efficacy and Safety of Once-Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease in Neonatal Patients
Davidson G, Wenzl TG, Thomson M, et al
J Pediatr. 2013;163:692-698
Study Summary
Proton pump inhibitors (PPIs) are approved for the treatment of reflux esophagitis in infants. However, PPIs are often prescribed to treat infant symptoms that may or may not be related to reflux, and the data supporting PPI effectiveness for nonspecific symptoms are limited.
This study used pH and impedance measurements coupled with cardiorespiratory and video monitoring of infants to assess whether esomeprazole was effective in reducing acid reflux, reflux events, and symptoms that parents associated with reflux. This was a randomized, double-blind, placebo-controlled trial conducted at 3 centers in 3 different countries.
All infants were 28-44 weeks gestational age and were in neonatal intensive care units when they were enrolled. On the basis of power analyses, the study intended to enroll 90 infants. However, only 52 were enrolled over 2.5 years; they were randomly assigned equally between the treatment and placebo groups.
The mean postnatal age among the infants was approximately 47 weeks, and the sample was approximately 60% girls. Although 80% of the infants were white, the enrollment of nonwhite infants was unbalanced between the treatment and placebo groups.