Montelukast in Very Low Birthweight Infants

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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.