"The principal aim of this trial is to determine the minimum effective dose of omeprazole in
neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry),
to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after
initiation of omeprazole.
The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon
other pHmetry parameters, (2) to characterize the population pharmacokinetics and
pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal
pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."