Montelukast in Very Low Birthweight Infants
Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants
2 other identifiers
interventional
9
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 2, 2012
August 1, 2012
4.3 years
June 25, 2007
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia
72 hours
Evaluate the preliminary safety of montelukast in pre-term neonates (single dose).
72 hours
Study Arms (1)
1
EXPERIMENTALNine 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- VLBW infants between 500 - 1500 gm birth-weight born at Good Samaritan Hospital, Cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days
You may not qualify if:
- Infants diagnosed with congenital malformations.
- Infants with an acute life threatening illness.
- Grade III or IV intra-ventricular hemorrhage.
- Patent ductus arteriosus being treated with indomethacin.
- Oral feedings are contra-indicated.
- Parents refuse consent.
- Attending physician does not wish the infant to be enrolled in the study.
- Infants with known hepatitis or HIV.
- Infants enrolled in any study using an investigational drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Good Samaritan Hospital
Cincinnati, Ohio, 45220-2489, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suhas Kallapur, MD
CCHMC/Good Samaritan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
March 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 2, 2012
Record last verified: 2012-08