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The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia (BPD)

Primary Purpose

Premature Birth, Infant, Very Low Birth Weight, Bronchopulmonary Dysplasia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Montelukast
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring montelukast, BPD, singulair, prematurity

Eligibility Criteria

2 Weeks - 10 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Montelukast

Control

Arm Description

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

Standard treatment of BPD and preterm infants

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event

Full Information

First Posted
October 26, 2012
Last Updated
February 9, 2015
Sponsor
Ajou University School of Medicine
Collaborators
Severance Hospital, Seoul National University Hospital, Gangnam Severance Hospital, Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT01717625
Brief Title
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Acronym
BPD
Official Title
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Severance Hospital, Seoul National University Hospital, Gangnam Severance Hospital, Korea University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Infant, Very Low Birth Weight, Bronchopulmonary Dysplasia
Keywords
montelukast, BPD, singulair, prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment of BPD and preterm infants
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair
Intervention Description
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
Primary Outcome Measure Information:
Title
Incidence of moderate to severe BPD or mortality
Description
At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality
Time Frame
corrected gestational age
Secondary Outcome Measure Information:
Title
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
Time Frame
1, 2, 4 weeks since starting study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moonsung Park, professor
Organizational Affiliation
Ajou University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ajou university medical center
City
Suwon
State/Province
Woncheon-dong, Yeongtong-gu,
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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