Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial
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ORIGINAL RESEARCH ARTICLE
Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial Petra Bestebreurtje1 · Barbara A. E. de Koning2 · Nel Roeleveld3 · Catherijne A. J. Knibbe4,5 · Dick Tibboel6 · Bianca van Groen6 · Cees P. van de Ven7 · Frans B. Plötz8,9 · Saskia N. de Wildt6,10
© The Author(s) 2020
Abstract Background and Objective Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole. Methods Infants (6–12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was
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