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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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GERD

Intervention / Treatment
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* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring | The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. | Baseline and end of treatment (10-14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux | Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included. | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Acidic Reflux Episodes | Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Weakly Acidic Reflux Episodes | Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Non Acidic Reflux Episodes | Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes | Number of reflux episodes based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Mean Bolus Clearance Time | Based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Mean Acid Clearance Time | Based on 24-hour impedance monitoring data | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Percentage Time With pH<4.0 | Percentage time with pH<4 during 24-hour pH monitoring | Baseline and end of treatment (10-14 days) | 
| Change From Baseline in Percentage Time With pH Within 4.0-6.9 | Percentage time with pH 4.0-6.9 during 24-hour pH monitoring | Baseline and end of treatment (10-14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, infants, GERD, reflux