Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

Inclusion Criteria:

• Full-term or gestational age >/= 28 to 44 weeks
• In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
• Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

• Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
• Patients with any condition that may require surgery during the course of the study
• Patients with acute respiratory distress within 72 hours prior to enrollment