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

NCT01717625 | Completed Phase 2 DMC

• 1 other identifier: AJIRB-MED-CT2-11-242
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

montelukast; BPD; singulair; prematurity

Outcome Measures

Primary Outcomes (1)

• 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 (1)

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

  1, 2, 4 weeks since starting study

Study Arms (2)

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

Montelukast DRUG

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

Also known as: Singulair

Montelukast

Eligibility Criteria

• Age: 2 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• congenital anomaly
• cardiovascular collapse
• investigator's opinion

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Severance Hospital: collaborator
• Seoul National University Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Korea University: collaborator

Study Sites (1)

Ajou university medical center

Suwon, Woncheon-dong, Yeongtong-gu,, 443-721, South Korea

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Interventions

montelukast

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Moonsung Park, professor

  Ajou University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

KR (1)