Lansoprazole in Preterm Infants With Reflux

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Preterm Infants; Gastrointestinal Reflux

Treatments: Drug: Lansoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01778101

Lanso_pilot

0720120860 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring

Enrollment: 5 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

lansoprazole

Experimental group

Description:

lansoprazole 1mg/kg twice a day for 14days

Treatment:

Drug: Lansoprazole