Montelukast in Very Low Birthweight Infants

Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492102

Enrollment

Registered

2007-06-27

Start date

2007-03-31

Completion date

2011-06-30

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

pharmacokinetics, Montelukast, bronchopulmonary dysplasia, Pharmacokinetics of Montelukast

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.

Interventions

DRUGMontelukast

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Days to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026