NCT01778101 - Lansoprazole in Preterm Infants With Reflux | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

5

Conditions

Preterm Infants Gastrointestinal Reflux

Interventions

LansoprazoleDRUG

lansoprazole 1mg/kg twice a day for 14days

Eligibility

Sex: ALLMax age: 4 Months

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

impedance pH monitoring

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

Time frame: day14

Secondary Outcomes

Symtomts of reflux_d5

apnea bradycardia desaturation regurgitate vomiting

Time frame: day 5

impedance pH monitoring_d10

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

Time frame: day10

impedance pH monitoring_d5

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

Time frame: day5

Symtomts of reflux_d10

apnea bradycardia desaturation regurgitate vomiting

Time frame: day 10

Symtomts of reflux_d14

apnea bradycardia desaturation regurgitate vomiting