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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Research Site
North Adelaide, Australia
Research Site
Aachen, Germany
Research Site
Sheffield, United Kingdom
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.
Time frame: Baseline and end of treatment (10-14 days)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Bolus Clearance Time
Based on 24-hour impedance monitoring data
Time frame: Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Acid Clearance Time
Based on 24-hour impedance monitoring data
Time frame: 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
Time frame: 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
Time frame: Baseline and end of treatment (10-14 days)