Overview

Lansoprazole in Preterm Infants With Reflux

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Dexlansoprazole
Lansoprazole
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