Lansoprazole in Preterm Infants With Reflux

Study Overview
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Brief Summary
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This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring

Official Title
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A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Conditions
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Preterm Infants, Gastrointestinal Reflux

Intervention / Treatment
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* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infant documented gastrointestinal reflux by 24hr pH monitoring Exclusion Criteria: unstable vital sings congenital anomaly in upper gastrointestinal tract incuding esophagus drug history of H2 blocker during last 1 week medication of warfarin, carbamazepine, phenytoin, rifampin renal or hepatic dysfunction inappropriate clinical conditions judged by researchers

Ages Eligible for Study
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Maximum Age: 4 Months

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lansoprazole<br>lansoprazole 1mg/kg twice a day for 14days | Drug: Lansoprazole<br>* lansoprazole 1mg/kg twice a day for 14days<br>* Other names: lanston LFDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impedance pH monitoring | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability | day14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symtomts of reflux_d5 | apnea bradycardia desaturation regurgitate vomiting | day 5 | 
| impedance pH monitoring_d10 | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability | day10 | 
| impedance pH monitoring_d5 | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability | day5 | 
| Symtomts of reflux_d10 | apnea bradycardia desaturation regurgitate vomiting | day 10 | 
| Symtomts of reflux_d14 | apnea bradycardia desaturation regurgitate vomiting | Symtomts of reflux_d14 day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, reflux, impedance, pH, monitoring, lansoprazole