Lansoprazole in Preterm Infants With Reflux

September 11, 2013 updated by: Han-Suk Kim, Seoul National University Hospital

A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-740
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lansoprazole
lansoprazole 1mg/kg twice a day for 14days
Drug: Lansoprazole
lansoprazole 1mg/kg twice a day for 14days
Other Names:
  • lanston LFDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impedance pH monitoring
Time Frame: 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
day14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symtomts of reflux_d5
Time Frame: day 5
apnea bradycardia desaturation regurgitate vomiting
day 5
impedance pH monitoring_d10
Time Frame: 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
day10
impedance pH monitoring_d5
Time Frame: 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
day5
Symtomts of reflux_d10
Time Frame: day 10
apnea bradycardia desaturation regurgitate vomiting
day 10
Symtomts of reflux_d14
Time Frame: Symtomts of reflux_d14 day 14
apnea bradycardia desaturation regurgitate vomiting
Symtomts of reflux_d14 day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 13, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lanso_pilot
  • 0720120860 (Other Grant/Funding Number: Konect)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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