drugset / Trial / NCT00004785
Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia
Phase 3
Completed
54 enrolled
National Center for Research Resources (NCRR)
University of Iowa · collab
RandomizedDouble-blindTreatment
Summary
OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment vs. placebo, initiated within the first month of life, on long-term pulmonary and developmental outcomes in premature infants with evolving bronchopulmonary dysplasia. II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal function.
Timeline
- Start
- 1995-11
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | — | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | — | Intravenous |