Clinical trial NCT00492102: Montelukast in Very Low Birthweight Infants
Official title: Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Keywords: pharmacokinetics
Montelukast
bronchopulmonary dysplasia
Pharmacokinetics of Montelukast
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-06-27
Enrollment: 9
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia
timeFrame: 72 hours
measure: Evaluate the preliminary safety of montelukast in pre-term neonates (single dose).
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: CCHMC/Good Samaritan
name: Suhas Kallapur, MD
role: PRINCIPAL_INVESTIGATOR
References: