Dose-Finding Study of Omeprazole on Gastric pH in Neonates with Gastro-Esophageal Acid Reflux Using a Bayesian Sequential Approach.

ABSTRACT:

Objective

Proton pump inhibitors are frequently administered on clinical symptoms in neonates but benefit remains controversial. Clinical trials validating omeprazole dosage in neonates are limited. The objective of this trial was to determine the minimum effective dose (MED) of omeprazole to treat pathological acid reflux in neonates using reflux index as surrogate marker.

Design

Double blind dose-finding trial with continual reassessment method of individual dose administration using a Bayesian approach, aiming to select drug dose as close as possible to the predefined target level of efficacy (with a credibility interval of 95%).

Setting

Neonatal Intensive Care unit of the Robert Debré University Hospital in Paris, France.

Patients

Neonates with a postmenstr

SUBMITTER: Kaguelidou F 

PROVIDER: S-EPMC5176365 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature