drugset / Trial / NCT00492102
Montelukast in Very Low Birthweight Infants
Phase 1
Completed
9 enrolled
Children's Hospital Medical Center, Cincinnati
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelBasic science
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).
Timeline
- Start
- 2007-03
- Primary completion
- 2011-06
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Montelukast | Other / unclassified | 0.15 mg | Oral |
| Subject | Montelukast | Other / unclassified | 0.2 mg | Oral |