Montelukast in Very Low Birthweight Infants
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First Received Date ICMJE | June 25, 2007 | ||||
Last Updated Date | August 1, 2012 | ||||
Start Date ICMJE | March 2007 | ||||
Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00492102 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | Montelukast in Very Low Birthweight Infants | ||||
Official Title ICMJE | Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants | ||||
Brief Summary | The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD). |
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Detailed Description | This study proposal will determine the pharmacokinetics (PK) of montelukast (cysteinyl leukotriene receptor-1 or CysLT1 inhibitor) in very low birth weight (VLBW) infants between 500 - 1500g birth weight at risk for developing bronchopulmonary dysplasia (BPD). Montelukast (Singulair) is a FDA approved specific CysLT1 antagonist widely used clinically in the prophylaxis of asthma in children older than 12 months of age and blocks leukotriene signaling in the lung. BPD shares some pathogenic mechanisms with asthma, however Cysteinyl LT receptor blockade has not been studied in preterm infants. Montelukast is metabolized by the cytochrome P450 system which is immature in the preterm infant and hence the need for this study. The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of BPD. The data will be used to design future efficacy trials of Montelukast in the prevention of bronchopulmonary dysplasia. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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Condition ICMJE | Bronchopulmonary Dysplasia | ||||
Intervention ICMJE | Drug: Montelukast
One oral dose of Montelukast 0.15mg (infants weighing 500-1000gm) or 0.2mg (infants weighing >1000gm). Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.
Other Name: Singulair |
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Study Arm (s) | Experimental: 1
Nine VLBW pre-term infants older than 7 days will be enrolled in the study and receive one oral dose of Montelukast based on weight. Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.
Intervention: Drug: Montelukast |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 9 | ||||
Completion Date | June 2011 | ||||
Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00492102 | ||||
Other Study ID Numbers ICMJE | CCHMC IRB# 05-05-22, TriHealth IRB# 05037-0505 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||
Collaborators ICMJE | Merck | ||||
Investigators ICMJE |
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Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |