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

Premature Birth Clinical Trial

— BPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717625
• Other study ID #: AJIRB-MED-CT2-11-242
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2012
• Last updated: February 9, 2015
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2015
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Montelukast
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source

Locations

Country	Name	City	State
Korea, Republic of	Ajou university medical center	Suwon	Woncheon-dong, Yeongtong-gu,

Sponsors (5)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Gangnam Severance Hospital, Korea University, Seoul National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event		1, 2, 4 weeks since starting study	Yes