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Lansoprazole in Preterm Infants With Reflux

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778101
First Posted: January 29, 2013
Last Update Posted: September 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
  Purpose
This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring

Condition Intervention Phase
Preterm Infants Gastrointestinal Reflux Drug: Lansoprazole Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Resource links provided by NLM:


Further study details as provided by Han-Suk Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Symtomts of reflux_d5 [ Time Frame: day 5 ]
    apnea bradycardia desaturation regurgitate vomiting

  • 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

  • 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

  • Symtomts of reflux_d10 [ Time Frame: day 10 ]
    apnea bradycardia desaturation regurgitate vomiting

  • Symtomts of reflux_d14 [ Time Frame: Symtomts of reflux_d14 day 14 ]
    apnea bradycardia desaturation regurgitate vomiting


Enrollment: 5
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lansoprazole
lansoprazole 1mg/kg twice a day for 14days
Drug: Lansoprazole
lansoprazole 1mg/kg twice a day for 14days
Other Name: lanston LFDT

  Eligibility

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778101


Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-740
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Han-Suk Kim, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01778101     History of Changes
Other Study ID Numbers: Lanso_pilot
0720120860 ( Other Grant/Funding Number: Konect )
First Submitted: January 13, 2013
First Posted: January 29, 2013
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Han-Suk Kim, Seoul National University Hospital:
preterm infants
reflux
impedance
pH
monitoring
lansoprazole

Additional relevant MeSH terms:
Premature Birth
Gastroesophageal Reflux
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action