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Completed

NCT Number: NCT01717625

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

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.

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Key information

Conditions

Premature Birth Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Infant, Very Low Birth Weight Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

2 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ajou university medical center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

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

Other names: Singulair

Primary outcomes

  1. Incidence of moderate to severe BPD or mortality

    Time frame: corrected gestational age

    At corrected gestational age 36 weeks, to compare the incidence of moderate to severe BPD or mortality

Secondary outcomes

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

    Time frame: 1, 2, 4 weeks since starting study

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Collaborators

  • Gangnam Severance Hospital
  • Korea University
  • Seoul National University Hospital
  • Severance Hospital

Registry information

Acronym: BPD

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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