Premature BirthPhase 2BPDNCT01717625
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
A Phase 2 study testing Montelukast in people with Premature Birth and Infant, Very Low Birth Weight, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 2 to 10 weeks
- Conditions the study is for
- Premature Birth, Infant, Very Low Birth Weight, Bronchopulmonary Dysplasia
- What is being tested?
- Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- congenital anomaly
- cardiovascular collapse
- investigator's opinion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university medical center
Suwon, Woncheon-dong, Yeongtong-gu,, 443-721
About this study
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.
- Being tested
- Montelukast
- Keywords
- montelukast, BPD, singulair, prematurity
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Montelukast |
| Control | No intervention | Standard treatment of BPD and preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: corrected gestational age
Secondary outcomes (1)
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
Measured: 1, 2, 4 weeks since starting study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Seoul National University Hospital, Gangnam Severance Hospital, Korea University
- Responsible party
- Principal investigator, Lee Janghoon, Ajou University School of Medicine
- Investigators
- Moonsung Park, professor, Study chair, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717625
- Sponsor's protocol ID
- AJIRB-MED-CT2-11-242
- Acronym
- BPD
- Status last verified
- Feb 2015
- First submitted
- 26 Oct 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT01717625
- Acronym / sponsor ID
- BPD / AJIRB-MED-CT2-11-242
- Keywords
- montelukast, BPD, singulair, prematurity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Severance Hospital, Seoul National University Hospital, Gangnam Severance Hospital, Korea University
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukastmontelukast 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 |
| Control | No intervention | –Standard treatment of BPD and preterm infants |
Who may qualify
- Ages
- 2 to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- congenital anomaly
- cardiovascular collapse
- investigator's opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastAlso: Singulaira leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source | Drug | Montelukast |
Primary outcome
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
1 secondary outcome
Oxygen Index. Use of mechanical ventilation, oxygen, systemic steroid. Weight gain, adverse event
Time frame: 1, 2, 4 weeks since starting study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moonsung Park, professor study chair
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Montelukast in people with Premature Birth and Infant, Very Low Birth Weight, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe BPD or mortality (time frame: corrected gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.