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Completed

NCT Number: NCT01946971

Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)

This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.

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Key information

Conditions

Premature Infants Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Reflux Gastrointestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University 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
  • symptoms suspecting gastroesophageal reflux

Exclusion criteria

  • unstable general conditions due infection or acute illness
  • congenital anomaly in upper gastrointestinal tract including esophagus
  • drug history of H2, proton pump inhibitor, blocker during last 1 week
  • medication of warfarin, carbamazepine, phenytoin, rifampin
  • inappropriate clinical conditions judged by researchers

Treatment and study plan

Lansoprazole

Drug

Other names: lanston LFDT

Placebo

Drug

Primary outcomes

  1. Acid reflux time (%)

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

Secondary outcomes

  1. Acid reflux frequency

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  2. Composite score

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  3. Acid reflux fraction

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  4. acid bolus reflux time/%,

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  5. nonacid bolus reflux time/%

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  6. bolus reflux time/%

    Time frame: day 0, day 7, day 14

    measured by 24hr pH impedance monitor

  7. I-GERQ GERD score

    Time frame: day 0, day 7, day 14

    I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 20, 2013
Registry last updated
Nov 19, 2014

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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