The Efficacy and Safety of Montelukast Sodium in the Prev... | NCT01717625

Studies
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia

NCT01717625

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Feb 10, 2015Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Premature Birth
Infant, Very Low Birth Weight
Bronchopulmonary Dysplasia

Interventions

Montelukast

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Oct 26, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee Janghoon, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Name	Class
Severance Hospital	OTHER
Seoul National University Hospital	OTHER
Gangnam Severance Hospital	OTHER
Korea University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is multicentered, prospective, randomized, opened, parallel, intervention study.

The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational age.

The investigators evaluate the first effectiveness through the morbidity and mortality of bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness through the oxygen index, the usage of mechanical ventilator about taking medicine after 2 Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial lavage fluid.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast	Experimental	montelukast sodium dosage < 1000g : 0.5 mg/D QD 1000g~1500g : 1.0 mg/D QD 1500g~2000g : 1.5 mg/D QD > 2000g : 2mg/D QD medication period : to discharge or GA 36wks	Drug: Montelukast
Control	No Intervention	Standard treatment of BPD and preterm infants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug	a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source	Montelukast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of moderate to severe BPD or mortality	At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality	corrected gestational age

Secondary Outcomes

Measure	Description	Time Frame
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event		1, 2, 4 weeks since starting study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm infants born at less than 32 weeks
Birth 14 days after, oxygen or artificial ventilation who are using patient
more than 20cal/kg/d by enteral feeding
written consent of the parents

Exclusion Criteria:

congenital anomaly
cardiovascular collapse
investigator's opinion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

10 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moonsung Park, professor	Ajou University Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou university medical center		Suwon	Woncheon-dong, Yeongtong-gu,	443-721	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D001997	Bronchopulmonary Dysplasia

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided