Lansoprazole in Preterm Infants With Reflux

A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01778101

Enrollment

Registered

2013-01-29

Start date

2013-01-31

Completion date

2013-06-30

Last updated

2013-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Reflux, Preterm Infants

Keywords

preterm infants, reflux, impedance, pH, monitoring, lansoprazole

Brief 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

Interventions

DRUGLansoprazole

lansoprazole 1mg/kg twice a day for 14days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 4 Months

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

Design outcomes

Primary

Measure	Time frame	Description
impedance pH monitoring	day14	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

Secondary

Measure	Time frame	Description
Symtomts of reflux_d5	day 5	apnea bradycardia desaturation regurgitate vomiting
impedance pH monitoring_d10	day10	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
impedance pH monitoring_d5	day5	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
Symtomts of reflux_d10	day 10	apnea bradycardia desaturation regurgitate vomiting
Symtomts of reflux_d14	Symtomts of reflux_d14 day 14	apnea bradycardia desaturation regurgitate vomiting

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026