Gastroesophageal Reflux, Premature Infants
Conditions
Brief summary
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.
Interventions
DRUGLansoprazole
DRUGPlacebo
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acid reflux time (%) | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite score | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
| Acid reflux fraction | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
| acid bolus reflux time/%, | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
| Acid reflux frequency | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
| bolus reflux time/% | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
| I-GERQ GERD score | day 0, day 7, day 14 | I-GERQ GERD score chart (Infant Gastroesophageal Reflux Questionnaire Gastroesophageal Reflux Disease) |
| nonacid bolus reflux time/% | day 0, day 7, day 14 | measured by 24hr pH impedance monitor |
Countries
South Korea
Outcome results
None listed