P0805 OMEPRAZOLE MAGNESIUM (OMEM) IN THE TREATMENT OF CHILDREN LESS THAN ONE YEAR OLD WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Introduction: GERD is a common problem in infancy and childhood. Regurgitation, vomit, irritability are commonest manifestations. Due to the actual controversy about the use of prokinetics, proton pump inhibitors PPIs have become an option of treatment. PPIs have been used in children older than one year with good results. There is little experience in children less than one year. AIM.- To know and to compare the clinical response in children with GERD treated with OMEM for one month period Methods: Prospective, longitudinal and comparative. 50 children under one year of age with GER were studied at Gastroenterology and Nutrition Department, Instituto Nacional Pediatrìa, México City, between June 2001–October 2002. 24 hs esophageal pH monitoring test was done using Boyles criteria before and after one month treatment with OMEM. Only children with abnormal pH test were included.Children were randomized in two groups. I.- OMEM, 0.5 and II.- 1.5 mgkgday. Single dose a day early morning, 20 min before first bottle of milk. CBC, Liver function test (AST,ALT,PT, etc) uryanalisis, serum glucose, urea, creatinine,electrolytes before and after treatment. Regurgitation, irritability were daily registered by parents. Children evaluated every 15 days. Parents were instructed about feeding technic.All children were fed with milk without any other modification.The protocol was approved for Research, Ethic Committees of the Hospital. Parental consent obtained in all cases. Statistic analysis done using 2-tailed Wilcoxon test a=0.05 Results: 22/25 children completed in group I, 21/25 in group II. 3 children from group 1 abandoned, one from Group II moved address. Median age: I.- 2.63 months (1–8), 14 males II.-2.95 months (1–7) 13 males. There was a significant inprovement of regurgitation, and irritability after one month treatment as well as of esophageal pH test. No difference between both groups. There was no changes in liver function, and other test. No clinical adverse reaction. Conclusion: OMEM is efficient and safety. Dose of OMEM for children less than 6 months old should prefered 0.5 mg/kg/day.