drugset / Trial / NCT01268215
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.
Timeline
- Start
- 2010-07
- Primary completion
- 2012-06
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | — | Other |
| Subject | Calfactant | Protein / enzyme biologic | — | Other |