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Lansoprazole in Preterm Infants With Reflux

Primary Purpose

Preterm Infants, Gastrointestinal Reflux

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lansoprazole
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infants focused on measuring preterm infants, reflux, impedance, pH, monitoring, lansoprazole

Eligibility Criteria

undefined - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lansoprazole

Arm Description

lansoprazole 1mg/kg twice a day for 14days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symtomts of reflux_d5
apnea bradycardia desaturation regurgitate vomiting
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
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
Symtomts of reflux_d10
apnea bradycardia desaturation regurgitate vomiting
Symtomts of reflux_d14
apnea bradycardia desaturation regurgitate vomiting

Full Information

First Posted
January 13, 2013
Last Updated
September 11, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01778101
Brief Title
Lansoprazole in Preterm Infants With Reflux
Official Title
A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Gastrointestinal Reflux
Keywords
preterm infants, reflux, impedance, pH, monitoring, lansoprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lansoprazole
Arm Type
Experimental
Arm Description
lansoprazole 1mg/kg twice a day for 14days
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
lanston LFDT
Intervention Description
lansoprazole 1mg/kg twice a day for 14days
Primary Outcome Measure Information:
Title
impedance pH monitoring
Description
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
Time Frame
day14
Secondary Outcome Measure Information:
Title
Symtomts of reflux_d5
Description
apnea bradycardia desaturation regurgitate vomiting
Time Frame
day 5
Title
impedance pH monitoring_d10
Description
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
Time Frame
day10
Title
impedance pH monitoring_d5
Description
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
Time Frame
day5
Title
Symtomts of reflux_d10
Description
apnea bradycardia desaturation regurgitate vomiting
Time Frame
day 10
Title
Symtomts of reflux_d14
Description
apnea bradycardia desaturation regurgitate vomiting
Time Frame
Symtomts of reflux_d14 day 14

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-740
Country
Korea, Republic of

12. IPD Sharing Statement

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Lansoprazole in Preterm Infants With Reflux

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