Lansoprazole in Preterm Infants With Reflux

Phase 2

Completed

• Conditions: Preterm Infants; Gastrointestinal Reflux
• Interventions: Drug: Lansoprazole

• Registration Number: NCT01778101
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lansoprazole	Lansoprazole	lansoprazole 1mg/kg twice a day for 14days

Primary Outcome Measures

Name	Time	Method
impedance pH monitoring	day14	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

Secondary Outcome Measures

Name	Time	Method
Symtomts of reflux_d5	day 5	apnea bradycardia desaturation regurgitate vomiting
impedance pH monitoring_d10	day10	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
impedance pH monitoring_d5	day5	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
Symtomts of reflux_d14	Symtomts of reflux_d14 day 14	apnea bradycardia desaturation regurgitate vomiting
Symtomts of reflux_d10	day 10	apnea bradycardia desaturation regurgitate vomiting

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of