Montelukast in Very Low Birthweight Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492102
• Other study ID #: CCHMC IRB# 05-05-22
• Secondary ID: TriHealth IRB# 0
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2007
• Last updated: August 1, 2012
• Start date: March 2007
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• Montelukast
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.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Evaluate the preliminary safety of montelukast in pre-term neonates (single dose).		72 hours	No