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

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Brief Title

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

Official Title

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Incidence of moderate to severe BPD or mortality

Secondary Outcome

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

Condition

Premature Birth

Intervention

Montelukast

Study Arms / Comparison Groups

 Montelukast
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

72

Start Date

November 2011

Completion Date

October 2013

Primary Completion Date

October 2013

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

Gender

All

Ages

2 Weeks - 10 Weeks

Accepts Healthy Volunteers

No

Contacts

Moonsung Park, professor, ,

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT01717625

Organization ID

AJIRB-MED-CT2-11-242

Responsible Party

Principal Investigator

Study Sponsor

Ajou University School of Medicine

Collaborators

 Severance Hospital

Study Sponsor

Moonsung Park, professor, Study Chair, Ajou University Medical Center

Verification Date

February 2015