Lansoprazole in Preterm Infants With Reflux

NCT ID: NCT01778101

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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Conditions

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Preterm Infants Gastrointestinal Reflux

Keywords

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preterm infants reflux impedance pH monitoring lansoprazole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lansoprazole

lansoprazole 1mg/kg twice a day for 14days

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

lansoprazole 1mg/kg twice a day for 14days

Interventions

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Lansoprazole

lansoprazole 1mg/kg twice a day for 14days

Intervention Type DRUG

Other Intervention Names

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lanston LFDT

Eligibility Criteria

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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
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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0720120860

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Lanso_pilot

Identifier Type: -

Identifier Source: org_study_id