Brief Title
Montelukast in Very Low Birthweight Infants
Official Title
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).
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia
Condition
Bronchopulmonary Dysplasia
Intervention
Montelukast
Study Arms / Comparison Groups
1
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
March 2007
Completion Date
June 2011
Primary Completion Date
June 2011
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Suhas Kallapur, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00492102
Organization ID
CCHMC IRB# 05-05-22
Secondary IDs
TriHealth IRB# 05037-0505
Responsible Party
Sponsor
Study Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Merck Sharp & Dohme Corp.
Study Sponsor
Suhas Kallapur, MD, Principal Investigator, CCHMC/Good Samaritan
Verification Date
August 2012