Is omeprazole as safe and effective as Lansoprazole in neonatal gastroesophageal reflux disease? A clinical trial neonatology

Objective: Gastroesophageal reflux (GER) is the reverse flow of stomach contents into the esophagus, which can become chronic and frequent in severe cases or the pathological form of Gastroesophageal Reflux Disease (GERD). Methods: This study was conducted to compare the safety and effectiveness of omeprazole with lansoprazole in the treatment of GERD in healthy neonates referred to Bahrami Children's Hospital as a double-blind randomized clinical trial, including ۹۰ neonates (age range ۱ -۲۸ days). In one group, ۴۵-term neonates aged ۳۸ to ۴۰ weeks were prescribed omeprazole at a dose of ۱ mg/kg/day, and in another group, ۴۵ neonates were prescribed lansoprazole at a dose of ۱ mg/kg/day. Recovery was considered if there was ۵۰% reduction of rumination, restlessness, regurgitation, vomiting, apnea, stridor, wheezing, pneumonia, convulsions, anemia, and improvement in weight gain and Sandifer's condition over one week and one month. Results: The two groups were not significantly different in terms of gender distribution, age at the first visit, gestational age, and birth weight. There was no significant difference between the overall scores of the two groups before the intervention. Still, one week and one month after the intervention, the total score was significantly lower in the lansoprazole group than in the omeprazole group. The total score in each study group decreased significantly during the study period. Conclusion: This study found that both omeprazole and lansoprazole were safe and effective in treating neonates with GERD; however, the effectiveness of lansoprazole was significantly higher than that of omeprazole.

کلیدواژه ها:

GERD ، Neonate ، Omeprazole ، Lansoprazole