Official Title: “Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants”

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).

Study Type: Interventional

Study Design: Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

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.

Intervention(s) in this Clinical Trial

• Drug: Montelukast
  • One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values

Primary Measures

• Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia
  • Time Frame: 72 hours
    Safety Issue?: No
• Evaluate the preliminary safety of montelukast in pre-term neonates (single dose).
  • Time Frame: 72 hours
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Overall Clinical Trial Officials and Contacts

Suhas Kallapur, MD Principal Investigator CCHMC/Good Samaritan  

Overall Contact: Suhas Kallapur, MD 513-636-3879 suhas.kallapur@cchmc.org

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00492102

Study ID Number: CCHMC IRB# 05-05-22

ClinicalTrials.gov Identifier: NCT00492102

Health Authority: United States: Food and Drug Administration