Lansoprazole in Preterm Infants With Reflux

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01778101
First received: January 13, 2013
Last updated: September 11, 2013
Last verified: September 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Seoul National University Hospital:

Primary Outcome Measures:
  • impedance pH monitoring [ Time Frame: day14 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    apnea bradycardia desaturation regurgitate vomiting

  • impedance pH monitoring_d10 [ Time Frame: day10 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    apnea bradycardia desaturation regurgitate vomiting

  • Symtomts of reflux_d14 [ Time Frame: Symtomts of reflux_d14 day 14 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01778101     History of Changes
Other Study ID Numbers: Lanso_pilot, 0720120860
Study First Received: January 13, 2013
Last Updated: September 11, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
preterm infants
reflux
impedance
pH
monitoring
lansoprazole

Additional relevant MeSH terms:
Esophagitis, Peptic
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Esophagitis
Gastroenteritis
Gastrointestinal Diseases
Peptic Ulcer
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014