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Completed

NCT Number: NCT01778101

Lansoprazole in Preterm Infants With 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

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Key information

Conditions

Preterm Infants Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Gastrointestinal Reflux

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Children's Hospital

Seoul, 110-740, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lansoprazole

Drug

lansoprazole 1mg/kg twice a day for 14days

Other names: lanston LFDT

Primary outcomes

  1. 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 outcomes

  1. Symtomts of reflux_d5

    Time frame: day 5

    apnea bradycardia desaturation regurgitate vomiting

  2. 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

  3. 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

  4. Symtomts of reflux_d10

    Time frame: day 10

    apnea bradycardia desaturation regurgitate vomiting

  5. Symtomts of reflux_d14

    Time frame: Symtomts of reflux_d14 day 14

    apnea bradycardia desaturation regurgitate vomiting

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 29, 2013
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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